Braincare BcAc-AF-1000
by Braincare Desenvolvimento E Inovacao Tecnologica SA 12 variants
Braincare BcAc-AF-1000 is a Class II device made by Braincare Desenvolvimento E Inovacao Tecnologica SA, cleared under FDA 510(k) K201989 on 8 Oct 2021 and listed in FDA GUDID since 11 Aug 2023 (UDI-DI 07908398200145), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07908398200145 | Date11 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201989 | Date8 Oct 2021 | StatusActive |
Official records
- AccessGUDID record 07908398200145
- FDA 510(k) database K201989
Across registries
- FDA 510(k) K201989 decided 8 Oct 2021 Active
- FDA GUDID UDI-DI 07908398200145 listed 11 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K201989
- Listed FDA GUDID 07908398200145
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Braincare
- Generic name
- Intracranial pressure monitor
- Model / reference
- BcAc-AF-1000
- Primary DI / UDI-DI
- 07908398200145
- 510(k) Number
- FDA product code
- GWM
- GMDN term
- Intracranial pressure monitor
- Device class
- Class II
- Regulation number
- 882.1620
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Size
- Length — 426 MillimeterWidth — 20 Millimeter
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