510(k) K905157

FLOSCOPE VASCULAR LAB. by Advance Medical Device, Inc. — Product Code JOP

K905157 is an FDA 510(k) premarket notification submitted by Advance Medical Device, Inc. for the device "FLOSCOPE VASCULAR LAB.". The FDA issued a decision of Substantially Equivalent on March 15, 1991. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880. Advance Medical Device, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1991
Date Received
November 16, 1990
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