510(k) K113632
K113632 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. for the device "DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 25, 2012. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 25, 2012
- Date Received
- Dec 5, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type
- 510(k)