The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Resuscitaire With Autobreath.
| Device ID | K120642 |
| 510k Number | K120642 |
| Device Name: | RESUSCITAIRE WITH AUTOBREATH |
| Classification | Warmer, Infant Radiant |
| Applicant | Draeger Medical Systems, Inc. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | Gale Winarsky |
| Correspondent | Gale Winarsky Draeger Medical Systems, Inc. 3135 QUARRY RD. Telford, PA 18969 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-02 |
| Decision Date | 2012-11-02 |
| Summary: | summary |