510(k) K082055
K082055 is an FDA 510(k) premarket notification submitted by Shenzhen Creative Industry Co., Ltd. for the device "MODEL PC-860 FETAL DOPPLER". The FDA issued a decision of Substantially Equivalent on Feb 6, 2009. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Shenzhen Creative Industry Co., Ltd. has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 6, 2009
- Date Received
- Jul 21, 2008
- 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
- 510(k)