WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
FDA 510(k) clearance K014121 · decided 2002-01-11
Clearance details
- K-number
- K014121
- Device name
- WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
- Applicant
- Nellcor Puritan Bennett, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-17
- Decision date
- 2002-01-11
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- DWJ
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR (P880013/S009) | Nellcor Puritan Bennett, Inc. | 2002-12-17 |
| HFV INFANT STAR VENTILATOR (P880013/S008) | Nellcor Puritan Bennett, Inc. | 1998-04-07 |
| HIGH FREQUENCY VENTILATOR (P880013/S007) | Nellcor Puritan Bennett, Inc. | 1997-06-24 |
| HFV STAR (P880013/S003) | Nellcor Puritan Bennett, Inc. | 1993-10-26 |
| HFV STAR (NEW MANUFACTURING SITE) (P880013/S002) | Nellcor Puritan Bennett, Inc. | 1993-08-11 |
| HFV STAR (P880013/S001) | Nellcor Puritan Bennett, Inc. | 1993-02-05 |
| INFANT STAR HIGH FREQUENCY VENTILATOR (P880013) | Nellcor Puritan Bennett, Inc. | 1990-01-19 |