CRITIKON SOFT BLOOD PRESSURE CUFF
FDA 510(k) clearance K974080 · decided 1998-05-18
Clearance details
- K-number
- K974080
- Device name
- CRITIKON SOFT BLOOD PRESSURE CUFF
- Applicant
- Johnson & Johnson Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-29
- Decision date
- 1998-05-18
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- DXQ
- Device class
- 2
- Regulation number
- 870.1120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tampa, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with recall (Z-1236-03) | GE Medical Systems Information Technologies | 2003-09-17 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-SORB ABSORBABLE DUSTING POWDER (N6264/S003) | Johnson & Johnson Medical, Inc. | 1985-09-10 |