The following data is part of a premarket notification filed by Impex Medical Systems, Inc. with the FDA for 1mhz Cw Doppler Transducer W/lily Antepartum #507.
| Device ID | K860621 |
| 510k Number | K860621 |
| Device Name: | 1MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #507 |
| Classification | Transducer, Ultrasonic, Obstetric |
| Applicant | IMPEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Contact | Kirk Olsen |
| Correspondent | Kirk Olsen IMPEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Product Code | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-19 |
| Decision Date | 1986-05-20 |