Disposable Manual Resuscitator— 510(k) K210288
Substantially EquivalentXiamen Compower Medical Tech. Co., Ltd.
FDA 510(k) clearance K210288 for Disposable Manual Resuscitator, Substantially Equivalent on 2021-08-26. Applicant: Xiamen Compower Medical Tech. Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Xiamen Compower Medical Tech. 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
- Traditional
- Location
- Xiamen, CN
Recent devices under product code BTM
view all- K251631 — The BAG manual resuscitator and accessories
- K243861 — butterflyBVM
- K221841 — EOlife®
- K212905 — Sotair Device
- K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
More clearances from Xiamen Compower Medical Tech. Co., Ltd.
view allAdverse 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.