The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Pk-141 Patient Cable.
| Device ID | K083674 |
| 510k Number | K083674 |
| Device Name: | PK-141 PATIENT CABLE |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-11 |
| Decision Date | 2009-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035479092443 | K083674 | 000 |