The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Imexdop Ct+.
| Device ID | K942441 |
| 510k Number | K942441 |
| Device Name: | IMEXDOP CT+ |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Contact | Dennis Newman |
| Correspondent | Dennis Newman IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-23 |
| Decision Date | 1994-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830028325 | K942441 | 000 |
| 00382830028318 | K942441 | 000 |
| 00382830028080 | K942441 | 000 |
| 00382830028066 | K942441 | 000 |