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 |