Identity
- Trade Name
- Component Monitoring System FDA UDI
- Generic Name
- Multi-purpose digital medical camera FDA UDI
- Device Name
- International model; optional camera that can be used to record video of the patient. FDA UDI
- Model / Reference
- CNS-VID-370 FDA UDI
- Description
- International model; optional camera that can be used to record video of the patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B485CNSVID3701 FDA UDI
- 510(k) Number
- K080217 FDA UDI
- FDA Product Code
- GWQ FDA UDIORT FDA UDIMHX FDA UDIOMA FDA UDIOLT FDA UDIMUD FDA UDI
- GMDN Term
- Multi-purpose digital medical camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI870.1025 FDA UDI870.2700 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
Yes
FDA UDI
Category: Multi-purpose digital medical camera
Component Monitoring System by Moberg Research, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose digital medical camera.
- TytoHome — TYTO CARE LTD · Class II
- TytoHome — TYTO CARE LTD · Class II
- TotalExam® Lite, 2.0 — GlobalMed Holdings, LLC · Class I
- Tyto Device — TYTO CARE LTD · Class II
- Tyto Device — TYTO CARE LTD · Class I
- TytoHome — TYTO CARE LTD · U
- TytoPro — TYTO CARE LTD · Class II
- DEXcam3™ intraoral cameras — DEXIS LLC · Class I
Cleared under the same submission
K080217 also covers:
- Component Monitoring System — Moberg Research, Inc.
- Component Monitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
- Component Neuromonitoring System — Moberg Research, Inc.
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
- Moberg Research, Inc.
Sources (1)
- FDA UDI 764dfa41-2c96-4f5b-afd4-7d6d5f38b174 34 fields · synced Jun 1, 2026