The following data is part of a premarket notification filed by Micromedical Industries, Ltd. with the FDA for Paceview.
| Device ID | K915627 |
| 510k Number | K915627 |
| Device Name: | PACEVIEW |
| Classification | Probe, Thermodilution |
| Applicant | MICROMEDICAL INDUSTRIES, LTD. 255 REVERE DR. SUITE 101 Northbrook, IL 60062 |
| Contact | Edward Hawfield |
| Correspondent | Edward Hawfield MICROMEDICAL INDUSTRIES, LTD. 255 REVERE DR. SUITE 101 Northbrook, IL 60062 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1992-03-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PACEVIEW 73739656 1556675 Dead/Cancelled |
MICROMEDICAL INDUSTRIES PTY LIMITED 1988-07-13 |