HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275
FDA 510(k) clearance K885079 · decided 1989-02-17
Clearance details
- K-number
- K885079
- Device name
- HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275
- Applicant
- Mennen Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-08
- Decision date
- 1989-02-17
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- LPP
- Device class
- 2
- Regulation number
- 868.2500
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Clarence, NY, 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 |
|---|---|---|
| TCM400 (K001866) | Radiometer Medical A/S | 2000-12-07 |
Recalls involving this device
No recalls on record reference this clearance.