OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
FDA 510(k) clearance K052396 · decided 2005-12-09
Clearance details
- K-number
- K052396
- Device name
- OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
- Applicant
- Oxysure Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-08-31
- Decision date
- 2005-12-09
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Frisco, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OxySure Model 615 disposable replacement cartridges, for portable oxygen generator. recall (Z-2253-2015) | Oxysure Systems, Inc. | 2015-07-24 |