SHARE INT'L TDM
FDA 510(k) clearance K832067 · decided 1983-10-27
Clearance details
- K-number
- K832067
- Device name
- SHARE INT'L TDM
- Applicant
- Share Int'L
- Decision
- Substantially Equivalent
- Date received
- 1983-06-27
- Decision date
- 1983-10-27
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- HCJ
- Device class
- 2
- Regulation number
- 882.1560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| SKIN GALVANOMETER (K823194) | Spelson Research Laboratories, Inc. | 1983-01-21 |
Recalls involving this device
No recalls on record reference this clearance.