The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Fetal Pulse Detector Model Dop-1.
| Device ID | K902190 |
| 510k Number | K902190 |
| Device Name: | FETAL PULSE DETECTOR MODEL DOP-1 |
| Classification | Monitor, Heart Sound, Fetal, Ultrasonic |
| Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Contact | Anthony Calderoni |
| Correspondent | Anthony Calderoni ADVANTAGE MEDICAL SYSTEMS, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Product Code | HEK |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1990-10-22 |