The following data is part of a premarket notification filed by Draeger Medical Ag & Co. Kg with the FDA for Ventstar Resuscitaire, Model Mp00311, Ventstar Resuscitaire Ceu, Model Mp00310.
| Device ID | K092029 |
| 510k Number | K092029 |
| Device Name: | VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road Telford, PA 18969 |
| Contact | Joyce Kilroy |
| Correspondent | Joyce Kilroy DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road Telford, PA 18969 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2010-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675026600 | K092029 | 000 |