CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
FDA 510(k) clearance K063268 · decided 2007-02-23
Clearance details
- K-number
- K063268
- Device name
- CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
- Applicant
- Hsiner Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-30
- Decision date
- 2007-02-23
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- BZD
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A recall (Z-2741-2018) | Compass Health Brands (Corporate Office) | 2018-08-20 |