510(k) 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 by
Flexicare Medical Limited.
— Product Code BTM
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2018
- Date Received
- June 15, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Ventilator, Emergency, Manual (Resuscitator)
- Device Class
- Class II
- Regulation Number
- 868.5915
- Review Panel
- AN
- Submission Type