K142769 is an FDA 510(k) clearance for the Fetal Doppler, a Monitor, Heart Sound, Fetal, Ultrasonic (Class II — Special Controls, product code HEK), submitted by Icare Newlife Technologies, Inc. (Beijing, CN). The FDA issued a Cleared decision on March 20, 2015, 176 days after receiving the submission on September 25, 2014. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K142769 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 2014 |
| Decision Date | March 20, 2015 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HEK — Monitor, Heart Sound, Fetal, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.2660 |