The following data is part of a premarket notification filed by Shenzhen Bestman Instrument Co., Ltd. with the FDA for Doppler Fetal Heartbeat Rate Detector.
| Device ID | K090510 |
| 510k Number | K090510 |
| Device Name: | DOPPLER FETAL HEARTBEAT RATE DETECTOR |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | SHENZHEN BESTMAN INSTRUMENT CO., LTD. KEJI NAN NO.12 RD. HI-TECH PARK, SHENZHEN Guangdong, CN |
| Contact | Kathy Guo |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-02-26 |
| Decision Date | 2010-04-29 |
| Summary: | summary |