K193191 is an FDA 510(k) clearance for the MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag. This device is classified as a Ventilator, Emergency, Powered (resuscitator) (Class II - Special Controls, product code BTL).
Submitted by Weinmann Emergency Medical Technology GmbH + Co. KG (Hamburg, DE). The FDA issued a Cleared decision on November 20, 2020, 367 days after receiving the submission on November 19, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5925.
| 510(k) Number | K193191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2019 |
| Decision Date | November 20, 2020 |
| Days to Decision | 367 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTL - Ventilator, Emergency, Powered (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5925 |