HSINER JET NEBULIZER, MODEL HS-31100— 510(k) K052811
Substantially EquivalentHsiner Co., Ltd.
FDA 510(k) clearance K052811 for HSINER JET NEBULIZER, MODEL HS-31100, Substantially Equivalent on 2005-12-21. 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
- Traditional
- Location
- Temecula, CA, US
Recent devices under product code CAF
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- 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
- K063268 — CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
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.