DISPOSABLE STETHOSCOPE HEAD COVER
FDA 510(k) clearance K935146 · decided 1994-07-11
Clearance details
- K-number
- K935146
- Device name
- DISPOSABLE STETHOSCOPE HEAD COVER
- Applicant
- Modern Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-28
- Decision date
- 1994-07-11
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- BZS
- Device class
- 1
- Regulation number
- 868.1930
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Fremont, CA, 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 |
|---|---|---|
| STETSKINS (K930118) | Nova Diversified Concepts | 1993-03-26 |
| SUPRA SCOPE (K801050) | Warner-Lambert Co. | 1980-05-14 |
Recalls involving this device
No recalls on record reference this clearance.