SLEEPWIZARD
FDA 510(k) clearance K964494 · decided 1997-02-04
Clearance details
- K-number
- K964494
- Device name
- SLEEPWIZARD
- Applicant
- Nellcor Puritan Bennett, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-08
- Decision date
- 1997-02-04
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MNR
- Device class
- 2
- Regulation number
- 868.2375
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Eden Prairie, MN, 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 |