Cerebrotech CMS-5000
FDA 510(k) clearance K171186 · decided 2017-12-08
Clearance details
- K-number
- K171186
- Device name
- Cerebrotech CMS-5000
- Applicant
- Cerebrotech Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2017-04-24
- Decision date
- 2017-12-08
- Days to decision
- 228 days
- Clearance type
- Traditional
- Product code
- QAF
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STEDI Scan Device (K253840) | Stroke DX | 2026-07-22 |
| Visor System (K182967) | Cerebrotech Medical Systems, Inc. | 2018-11-23 |
Recalls involving this device
No recalls on record reference this clearance.