COWBOY X
FDA 510(k) clearance K944567 · decided 1995-06-21
Clearance details
- K-number
- K944567
- Device name
- COWBOY X
- Applicant
- Kinetic Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-19
- Decision date
- 1995-06-21
- Days to decision
- 275 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. recall (Z-0663-2010) | KCI USA, Inc. | 2010-01-25 |