Identity
- Trade Name
- ProSim 8 FDA UDI
- Generic Name
- Multi-parameter device tester FDA UDI
- Device Name
- Vital Signs Patient Simulator FDA UDI
- Model / Reference
- PROSIM 8 FDA UDI
- Description
- Vital Signs Patient Simulator FDA UDI
Identifiers
- Catalog Number
- 3979409 FDA UDI
- Primary DI / UDI-DI
- 00850540007065 FDA UDI
- 510(k) Number
- K110429 FDA UDI
- FDA Product Code
- DRT FDA UDI
- GMDN Term
- Multi-parameter device tester FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-parameter device tester
ProSim 8 by Fluke Electronics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-parameter device tester.
- HDM97 — IBP Medical GmbH · Class II
- MesaLabs — MESA LABORATORIES, INC. · Class II
- HDM97 — IBP Medical GmbH · Class II
- Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips — SERIM RESEARCH CORP. · Class II
- Serim® GUARDIAN™ Residual Peroxide Test Strips — SERIM RESEARCH CORP. · Class II
- HDM97 — IBP Medical GmbH · Class II
- Myron L® Company — MYRON L COMPANY · Class II
- Myron L® Company — MYRON L COMPANY · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fluke Electronics Corporation
Sources (1)
- FDA UDI 20d6daf0-cec2-4fa0-85e0-d59696689eed 36 fields · synced May 30, 2026