The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Flat Vascular Probe.
Device ID | K896613 |
510k Number | K896613 |
Device Name: | FLAT VASCULAR PROBE |
Classification | Flowmeter, Blood, Cardiovascular |
Applicant | IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
Contact | Ed Bistrick |
Correspondent | Ed Bistrick IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
Product Code | DPW |
CFR Regulation Number | 870.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-21 |
Decision Date | 1990-02-16 |