510(k) K180419
K180419 is an FDA 510(k) premarket notification submitted by Shenzhen Imdk Medical Technology Co., Ltd. for the device "Ultrasonic Doppler (Model YM-2T8)". The FDA issued a decision of Substantially Equivalent on July 19, 2018. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Shenzhen Imdk Medical Technology Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2018
- Date Received
- February 15, 2018
- 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