Identity
- Trade Name
- Temporal Monitoring Headset FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system probe FDA UDI
- Model / Reference
- 40-00010 FDA UDI
Identifiers
- Catalog Number
- NA – MOUNT1 FDA UDI
- Primary DI / UDI-DI
- 00850681007030 FDA UDI
- 510(k) Number
- K160442 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- Not 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
Temporal Monitoring Headset by Novasignal Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K160442 also covers:
- 2-MHz Transducer, Handheld — Novasignal Corporation
- 2Mhz Monitoring Transducer - 8 foot — Novasignal Corporation
- Lucid Transcranial Doppler Ultrasound System (Lucid TCD) — Novasignal Corporation
- Remote Control Accessory — Novasignal Corporation
- Temporal Monitoring Headframe — Novasignal Corporation
- Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack — Novasignal Corporation
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 |
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Manufacturer
- Manufacturer
- Novasignal Corporation
Sources (1)
- FDA UDI b7848b60-9bd6-4640-8fec-aae5a71a517e 35 fields · synced Jun 8, 2026