DISPOSABLE DIAPHRAGM DOMES
FDA 510(k) clearance K820355 · decided 1982-03-04
Clearance details
- K-number
- K820355
- Device name
- DISPOSABLE DIAPHRAGM DOMES
- Applicant
- Medex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-08
- Decision date
- 1982-03-04
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- DRS
- Device class
- 2
- Regulation number
- 870.2850
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medex LOGICAL CATH LAB KIT, List Number M20754 recall (Z-0739-2024) | Smiths Medical Asd Inc | 2024-01-17 |