Identity
- Trade Name
- OptiMap Amplifer FDA UDI
- Generic Name
- Multiple physiological signal amplifier FDA UDI
- Device Name
- OptiMap Amplifier FDA UDI
- Model / Reference
- FG0007 FDA UDI
- Description
- OptiMap Amplifier FDA UDI
Identifiers
- Catalog Number
- OPTI-AMP FDA UDI
- Primary DI / UDI-DI
- 00850064686005 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Multiple physiological signal amplifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 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
Yes
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
Yes
FDA UDI
Category: Multiple physiological signal amplifier
OptiMap Amplifer by Cortex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple physiological signal amplifier.
- SEP 1 Channel Fiber Optic Cable (Power) — Intelligent Hearing Systems Corp. · Class II
- g.Nautilus PRO — g.tec medical engineering GmbH · Class II
- MyoVision Wirefree System — PRECISION BIOMETRICS INC · Class I
- g.Nautilus PRO — g.tec medical engineering GmbH · Class II
- Ochs Labs EEG Amplifier — SOUTHEAST SIGNAL, INC · Class II
- SERIES-5 MyoVision ScanVision — PRECISION BIOMETRICS INC · Class I
- Phoenix EEG Amplifier — SOUTHEAST SIGNAL, INC · Class II
- Phoenix EEG Amplifier — SOUTHEAST SIGNAL, INC · Class II
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
- Cortex, Inc.
Sources (1)
- FDA UDI a5efd44e-6b42-4965-ad06-fbbbbad6651e 34 fields · synced May 30, 2026