The following data is part of a premarket notification filed by Micromedical with the FDA for Paceview.
| Device ID | K895535 |
| 510k Number | K895535 |
| Device Name: | PACEVIEW |
| Classification | Analyzer, Pacemaker Generator Function, Indirect |
| Applicant | MICROMEDICAL 47 W. HANOVER ST. SUITE 4 Gettysburg, PA 17325 |
| Contact | Wesley Kulp |
| Correspondent | Wesley Kulp MICROMEDICAL 47 W. HANOVER ST. SUITE 4 Gettysburg, PA 17325 |
| Product Code | KRE |
| CFR Regulation Number | 870.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-13 |
| Decision Date | 1990-03-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PACEVIEW 73739656 1556675 Dead/Cancelled |
MICROMEDICAL INDUSTRIES PTY LIMITED 1988-07-13 |