The following data is part of a premarket notification filed by Biotronik, Gmbh & Co. with the FDA for Pk-55 Andover Medical Part #5455 Label Change.
| Device ID | K901332 |
| 510k Number | K901332 |
| Device Name: | PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego, OR 97035 -5369 |
| Contact | Stout, Md |
| Correspondent | Stout, Md BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego, OR 97035 -5369 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-22 |
| Decision Date | 1990-05-09 |