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 |