The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Era 300 Dual Chamber Pacing System Analyzer.
| Device ID | K964190 |
| 510k Number | K964190 |
| Device Name: | ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Joseph J Schwoebel |
| Correspondent | Joseph J Schwoebel BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-21 |
| Decision Date | 1997-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035479056353 | K964190 | 000 |
| 04035479015473 | K964190 | 000 |
| 04035479010355 | K964190 | 000 |