AESTHESIOMETER
FDA 510(k) clearance K874300 · decided 1987-11-06
Clearance details
- K-number
- K874300
- Device name
- AESTHESIOMETER
- Applicant
- Orthopedic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-10-20
- Decision date
- 1987-11-06
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- GWI
- Device class
- 1
- Regulation number
- 882.1200
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Hayward, 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 |
|---|---|---|
| TCD OR TCD NEUROPATHY STAR (K944234) | Jcm Management & Planning Co. | 1995-03-08 |
Recalls involving this device
No recalls on record reference this clearance.