SOMATOSENSORY STIMULUS SYSTEM
FDA 510(k) clearance K913604 · decided 1991-12-09
Clearance details
- K-number
- K913604
- Device name
- SOMATOSENSORY STIMULUS SYSTEM
- Applicant
- Biomagnetic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-14
- Decision date
- 1991-12-09
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- GZP
- Device class
- 2
- Regulation number
- 882.1880
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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|---|---|---|
| EyeStat (K191700) | Blinktbi, Inc. | 2019-12-09 |
Recalls involving this device
No recalls on record reference this clearance.