510(k) K912409

MODEL HD-207 BIDIRECTIONAL VELOCITY METER by Koven and Assoc., Inc. — Product Code JOP

K912409 is an FDA 510(k) premarket notification submitted by Koven and Assoc., Inc. for the device "MODEL HD-207 BIDIRECTIONAL VELOCITY METER". The FDA issued a decision of Substantially Equivalent on December 23, 1991. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880. Koven and Assoc., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1991
Date Received
May 31, 1991
Clearance Type
Traditional
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