EyeStat
FDA 510(k) clearance K191700 · decided 2019-12-09
Clearance details
- K-number
- K191700
- Device name
- EyeStat
- Applicant
- Blinktbi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-06-25
- Decision date
- 2019-12-09
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- GZP
- Device class
- 2
- Regulation number
- 882.1880
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Charleston, SC, 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 |
|---|---|---|
| SOMATOSENSORY STIMULUS SYSTEM (K913604) | Biomagnetic Technologies, Inc. | 1991-12-09 |
Recalls involving this device
No recalls on record reference this clearance.