510(k) K071730

STUDIODOP VICORDER by Skidmore Medical, Limited — Product Code JOP

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