K902190 is an FDA 510(k) clearance for the FETAL PULSE DETECTOR MODEL DOP-1. This device is classified as a Monitor, Heart Sound, Fetal, Ultrasonic (Class II - Special Controls, product code HEK).
Submitted by Advanced Medical Systems, Inc. (Hamden, US). The FDA issued a Cleared decision on October 22, 1990, 159 days after receiving the submission on May 16, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K902190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1990 |
| Decision Date | October 22, 1990 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HEK — Monitor, Heart Sound, Fetal, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2660 |