DEVILBISS 5 LITER OXYGEN CONCENTRATOR
FDA 510(k) clearance K991722 · decided 1999-11-03
Clearance details
- K-number
- K991722
- Device name
- DEVILBISS 5 LITER OXYGEN CONCENTRATOR
- Applicant
- Sunrise Medical Hhg, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-20
- Decision date
- 1999-11-03
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Somerset, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sunrise Medical Hhg
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen recall (Z-0617-2009) | Sunrise Medical | 2008-12-30 |