510(k) K142769
K142769 is an FDA 510(k) premarket notification submitted by Icare Newlife Technologies, Inc. for the device "Fetal Doppler". The FDA issued a decision of Substantially Equivalent on March 20, 2015. The device falls under product code HEK (Monitor, Heart Sound, Fetal, Ultrasonic), a Class II device regulated under 21 CFR 884.2660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2015
- Date Received
- September 25, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Heart Sound, Fetal, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- OB
- Submission Type