510(k) K170663
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer by
Foremount Enterprise Co., Ltd.
— Product Code BTM
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2018
- Date Received
- March 6, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Emergency, Manual (Resuscitator)
- Device Class
- Class II
- Regulation Number
- 868.5915
- Review Panel
- AN
- Submission Type