SUPRA SCOPE
FDA 510(k) clearance K801050 · decided 1980-05-14
Clearance details
- K-number
- K801050
- Device name
- SUPRA SCOPE
- Applicant
- Warner-Lambert Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-05-05
- Decision date
- 1980-05-14
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- BZS
- Device class
- 1
- Regulation number
- 868.1930
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- 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 |
|---|---|---|
| DISPOSABLE STETHOSCOPE HEAD COVER (K935146) | Modern Medical Devices, Inc. | 1994-07-11 |
| STETSKINS (K930118) | Nova Diversified Concepts | 1993-03-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S004) | Warner-Lambert Co. | 1988-04-12 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S003) | Warner-Lambert Co. | 1986-03-17 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S002) | Warner-Lambert Co. | 1986-03-17 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S001) | Warner-Lambert Co. | 1983-11-25 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024) | Warner-Lambert Co. | 1982-03-04 |