VPAP Pediatric Face Mask
FDA 510(k) clearance K251888 · decided 2026-03-12
Clearance details
- K-number
- K251888
- Device name
- VPAP Pediatric Face Mask
- Applicant
- Hsiner Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-20
- Decision date
- 2026-03-12
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Taichung City, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.