The following data is part of a premarket notification filed by Corscience Gmbh & Co. Kg with the FDA for Bt3/6, Bt12.
| Device ID | K082077 |
| 510k Number | K082077 |
| Device Name: | BT3/6, BT12 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CORSCIENCE GMBH & CO. KG 700-706 SECO RD Monroeville, PA 15146 |
| Contact | Patrik Karem |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-23 |
| Decision Date | 2008-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05099169413030 | K082077 | 000 |
| 05099169413337 | K082077 | 000 |
| 05099169413306 | K082077 | 000 |