K181583 is an FDA 510(k) clearance for the 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. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II - Special Controls, product code BTM).
Submitted by Flexicare Medical Limited. (Mountain Ash, GB). The FDA issued a Cleared decision on December 7, 2018, 175 days after receiving the submission on June 15, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K181583 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2018 |
| Decision Date | December 07, 2018 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTM - Ventilator, Emergency, Manual (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5915 |