GALVANIC UNIT
FDA 510(k) clearance K790949 · decided 1979-08-16
Clearance details
- K-number
- K790949
- Device name
- GALVANIC UNIT
- Applicant
- Rami International Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-05-21
- Decision date
- 1979-08-16
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- ISB
- Device class
- 2
- Regulation number
- 890.1850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- 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 |
|---|---|---|
| IMPULS 3, IT SELECTOR (K842805) | Robert Bosch Corp. | 1984-08-01 |
| PIRD-Y (K842262) | Pirdy, Inc. | 1984-06-28 |
| MAXICEPTOR (K780632) | Med General | 1978-08-14 |
| FIGURETRIM (K780730) | Jay-Mar INternational Enterprises, IN | 1978-05-09 |
Recalls involving this device
No recalls on record reference this clearance.