The following data is part of a premarket notification filed by Weinmann Emergency Medical Technology Gmbh + Co. Kg with the FDA for Medumat Easy Cpr, Medumat Easy Cpr With Bag.
| Device ID | K193191 |
| 510k Number | K193191 |
| Device Name: | MEDUMAT Easy CPR, MEDUMAT Easy CPR With Bag |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | Weinmann Emergency Medical Technology GmbH + Co. KG Frohbösestraße 12 Hamburg, DE 22525 |
| Contact | Kristin Ratschiller |
| Correspondent | Kristin Ratschiller Weinmann Emergency Medical Technology GmbH + Co. KG Frohbösestraße 12 Hamburg, DE 22525 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-19 |
| Decision Date | 2020-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04054685271619 | K193191 | 000 |
| 04054685271602 | K193191 | 000 |
| 04054685271596 | K193191 | 000 |
| 04054685271589 | K193191 | 000 |
| 04054685129996 | K193191 | 000 |
| 04054685091408 | K193191 | 000 |
| 04054685268947 | K193191 | 000 |
| 04054685091286 | K193191 | 000 |