510(k) K071730
K071730 is an FDA 510(k) premarket notification submitted by Skidmore Medical, Limited for the device "STUDIODOP VICORDER". The FDA issued a decision of Substantially Equivalent on December 20, 2007. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2007
- Date Received
- June 25, 2007
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 870.2880
- Review Panel
- CV
- Submission Type