HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS— 510(k) K082009
Substantially EquivalentHsiner Co., Ltd.
FDA 510(k) clearance K082009 for HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS, Substantially Equivalent on 2008-08-22. Applicant: Hsiner Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hsiner Co., Ltd.
- Product code
- Code CAF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Temecula, CA, US
Recent devices under product code CAF
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
- K063268 — CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
- K053466 — HSINER RESUSCITATOR
Adverse events under product code CAF
product code CAF- Death
- 22
- Injury
- 125
- Malfunction
- 613
- Other
- 11
- Total
- 771
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.