LP Testing Software (UDI 04538612916014)
Manufactured by Fukuda Denshi Co., Ltd.
Device Regulatory Overview
The LP Testing Software (Model/Catalog Number: FP-908LP) is a medical device manufactured by Fukuda Denshi Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Z12050382 within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient...
Technical Specifications
- Model Number
- FP-908LP
- Product Code / EMDN
- Z12050382
- Device Name
- Electrocardiograph
- Database Sync Date
- 2026-08-09 16:46:31
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of LP Testing Software?
The registered manufacturer of record for LP Testing Software is Fukuda Denshi Co., Ltd..
What is the Primary UDI-DI identifier for LP Testing Software?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04538612916014.
What classification code is assigned to this device?
This device is registered under product classification code Z12050382.
Similar Classification Devices (Z12050382)
Other Devices by Fukuda Denshi Co., Ltd.
- → Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.
- → Clearode
- → Air Hose
- → Patient Cable
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint