Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer— 510(k) K170663
Substantially EquivalentForemount Enterprise Co., Ltd.
FDA 510(k) clearance K170663 for Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer, Substantially Equivalent on 2018-05-11. Applicant: Foremount Enterprise Co., Ltd..
Clearance details
- Applicant
- Foremount Enterprise Co., Ltd.
- Product code
- Code BTM
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung City, TW
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.