The following data is part of a premarket notification filed by Maquet Gmbh And Co. Kg with the FDA for Bora Up 2080, Bora Up 2080 Op And Bora Up 2080 Mounting.
| Device ID | K092903 |
| 510k Number | K092903 |
| Device Name: | BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | MAQUET GMBH AND CO. KG KEHLER STRASSE 31 Rastatt, DE 76437 |
| Contact | Annette Jakob |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2009-12-01 |
| Summary: | summary |