CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235— 510(k) K063268
Substantially EquivalentHsiner Co., Ltd.
FDA 510(k) clearance K063268 for CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235, Substantially Equivalent on 2007-02-23. Applicant: Hsiner Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hsiner Co., Ltd.
- Product code
- Code BZD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Temecula, CA, US
Recent devices under product code BZD
view allMore clearances from Hsiner Co., Ltd.
view all- K251888 — VPAP Pediatric Face Mask
- K102120 — NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
- K091185 — 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
- K082009 — HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
- K053466 — HSINER RESUSCITATOR
Adverse events under product code BZD
product code BZD- Death
- 4,440
- Injury
- 53,099
- Malfunction
- 213,222
- Other
- 17
- Total
- 270,778
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K063268
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063268.
Data sourced from openFDA. This site is unofficial and independent of the FDA.