SKIN GALVANOMETER
FDA 510(k) clearance K823194 · decided 1983-01-21
Clearance details
- K-number
- K823194
- Device name
- SKIN GALVANOMETER
- Applicant
- Spelson Research Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-10-26
- Decision date
- 1983-01-21
- Days to decision
- 87 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 |
|---|---|---|
| SHARE INT'L TDM (K832067) | Share Int'L | 1983-10-27 |
Recalls involving this device
No recalls on record reference this clearance.