510(k) K220245
K220245 is an FDA 510(k) premarket notification submitted by Contec Medical Systems Co.,Ltd for the device "Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)". The FDA issued a decision of Substantially Equivalent on September 28, 2022. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Contec Medical Systems Co.,Ltd has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2022
- Date Received
- January 28, 2022
- 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