HSINER RESUSCITATOR— 510(k) K053466
Substantially EquivalentHsiner Co., Ltd.
FDA 510(k) clearance K053466 for HSINER RESUSCITATOR, Substantially Equivalent on 2006-03-22. Applicant: Hsiner Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hsiner Co., Ltd.
- Product code
- Code BTM
- Device class
- Class 2
- Regulation
- 21 CFR 868.5915
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Temecula, CA, US
Recent devices under product code BTM
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
- K063268 — CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
Adverse events under product code BTM
product code BTM- Death
- 19
- Other
- 2
- Total
- 21
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.