Identity
- Trade Name
- C6 Sensor FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Model / Reference
- 02-01606 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B146C6D10 FDA UDI
- 510(k) Number
- K153473 FDA UDI
- FDA Product Code
- DSI FDA UDI
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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: Electrocardiographic ambulatory recorder
C6 Sensor by Braemar Manufacturing, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153473 also covers:
- BTP-1000M — Braemar Manufacturing, LLC
- BTP-1000S — Braemar Manufacturing, LLC
- BTP-1000S Monitor — Braemar Manufacturing, LLC
- C6 Monitor — Braemar Manufacturing, LLC
- C6 Monitor A10e, Sprint — Braemar Manufacturing, LLC
- C6 Monitor A10e, Verizon — Braemar Manufacturing, LLC
- C6 Monitor A13, T Mobile — Braemar Manufacturing, LLC
- C6 Monitor A13, Verizon — Braemar Manufacturing, LLC
- C6 Monitor UGW — Braemar Manufacturing, LLC
- C6 Sensor 2.0 rebuilt — Braemar Manufacturing, LLC
- C6 Sensor 2.5 rebuilt — Braemar Manufacturing, LLC
- C6 Sensor 3.0 — Braemar Manufacturing, LLC
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
- Braemar Manufacturing, LLC
Sources (1)
- FDA UDI a75bd2e5-ff26-4996-82f8-044bf895843b 33 fields · synced Jun 9, 2026