510(k) K172780
K172780 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "SD1 Ultrasonic Pocket Doppler". The FDA issued a decision of Substantially Equivalent on June 6, 2018. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2018
- Date Received
- September 14, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Ultrasonic, Fetal
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- OB
- Submission Type