TCD OR TCD NEUROPATHY STAR
FDA 510(k) clearance K944234 · decided 1995-03-08
Clearance details
- K-number
- K944234
- Device name
- TCD OR TCD NEUROPATHY STAR
- Applicant
- Jcm Management & Planning Co.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-31
- Decision date
- 1995-03-08
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- GWI
- Device class
- 1
- Regulation number
- 882.1200
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Wilmington, DE, 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 |
|---|---|---|
| AESTHESIOMETER (K874300) | Orthopedic Systems, Inc. | 1987-11-06 |
Recalls involving this device
No recalls on record reference this clearance.