The following data is part of a premarket notification filed by Draeger Medical Ag & Co. Kg with the FDA for Classicstar Nv Se And Novastar Nv Se And Aav Full Face Masks.
| Device ID | K081743 |
| 510k Number | K081743 |
| Device Name: | CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAEGER MEDICAL AG & CO. KG 53/55 MOISLINGER ALLEE Luebeck, DE 23542 |
| Contact | Karin Luebbers |
| Correspondent | Karin Luebbers DRAEGER MEDICAL AG & CO. KG 53/55 MOISLINGER ALLEE Luebeck, DE 23542 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-19 |
| Decision Date | 2008-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675251712 | K081743 | 000 |
| 04048675041122 | K081743 | 000 |
| 04048675041139 | K081743 | 000 |
| 04048675253433 | K081743 | 000 |
| 04048675253440 | K081743 | 000 |
| 04048675253457 | K081743 | 000 |
| 04048675250371 | K081743 | 000 |
| 04048675250807 | K081743 | 000 |
| 04048675250814 | K081743 | 000 |
| 04048675250821 | K081743 | 000 |
| 04048675250838 | K081743 | 000 |
| 04048675250845 | K081743 | 000 |
| 04048675251613 | K081743 | 000 |
| 04048675251705 | K081743 | 000 |
| 04048675041115 | K081743 | 000 |