510(k) K090510
K090510 is an FDA 510(k) premarket notification submitted by Shenzhen Bestman Instrument Co., Ltd. for the device "DOPPLER FETAL HEARTBEAT RATE DETECTOR". The FDA issued a decision of Substantially Equivalent on April 29, 2010. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Shenzhen Bestman Instrument Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2010
- Date Received
- February 26, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Monitor, Ultrasonic, Fetal
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- OB
- Submission Type