The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Cardiomemo.
| Device ID | K803286 |
| 510k Number | K803286 |
| Device Name: | CARDIOMEMO |
| Classification | Analyzer, Pacemaker Generator Function, Indirect |
| Applicant | INSTROMEDIX, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KRE |
| CFR Regulation Number | 870.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-30 |
| Decision Date | 1981-03-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CARDIOMEMO 73294342 1190542 Dead/Cancelled |
Instromedix, Inc. 1981-01-26 |