DEVILBISS PD1000
FDA 510(k) clearance K020329 · decided 2002-06-19
Clearance details
- K-number
- K020329
- Device name
- DEVILBISS PD1000
- Applicant
- Sunrise Medical Hhg, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-01-31
- Decision date
- 2002-06-19
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- NFB
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Somerset, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder recall (Z-0731-2007) | Sunrise Medical | 2007-04-21 |
| 535D-X CF Continuous Flow Cylinder recall (Z-0732-2007) | Sunrise Medical | 2007-04-21 |