K090510 is an FDA 510(k) clearance for the DOPPLER FETAL HEARTBEAT RATE DETECTOR. This device is classified as a Monitor, Ultrasonic, Fetal (Class II - Special Controls, product code KNG).
Submitted by Shenzhen Bestman Instrument Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on April 29, 2010, 427 days after receiving the submission on February 26, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K090510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2009 |
| Decision Date | April 29, 2010 |
| Days to Decision | 427 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KNG - Monitor, Ultrasonic, Fetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2660 |