The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Pocket Dop 3.
| Device ID | K910462 |
| 510k Number | K910462 |
| Device Name: | POCKET DOP 3 |
| Classification | Monitor, Blood-flow, Ultrasonic |
| 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 | HEP |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-04 |
| Decision Date | 1991-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830028189 | K910462 | 000 |
| 00382830028172 | K910462 | 000 |
| 00382830028004 | K910462 | 000 |