OLYMPIC TRANS-LITE
FDA 510(k) clearance K920782 · decided 1992-03-27
Clearance details
- K-number
- K920782
- Device name
- OLYMPIC TRANS-LITE
- Applicant
- Olympic Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-02-20
- Decision date
- 1992-03-27
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- KYT
- Device class
- 1
- Regulation number
- 880.6350
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Seattle, WA, 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 |
|---|---|---|
| SUN-LITE WHITE SPOT (K841588) | Suncoast Medical Manufacturers, Inc. | 1984-05-22 |
| C-LITE (K841589) | Suncoast Medical Manufacturers, Inc. | 1984-05-22 |
| PENLIGHT/SWAB HOLDER (K791001) | Concept, Inc. | 1979-06-22 |
| PENLIGHTS (K781228) | Abco Dealers, Inc. | 1978-09-07 |
| TYCOS DIAGNOSTIC PENLIGHT (K760972) | Taylor Instrument Analytics Co. | 1977-01-26 |
Recalls involving this device
No recalls on record reference this clearance.