The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Imexlab 3000 Vascular Diagnostic Recorder.
| Device ID | K882138 |
| 510k Number | K882138 |
| Device Name: | IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER |
| 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 | 1988-05-20 |
| Decision Date | 1988-11-07 |