510(k) K840385

VIDEO PRINT by Advanced Instruments, Inc. — Product Code LMC

K840385 is an FDA 510(k) premarket notification submitted by Advanced Instruments, Inc. for the device "VIDEO PRINT". The FDA issued a decision of Substantially Equivalent on February 27, 1984. The device falls under product code LMC (Camera, Multi Format, Radiological), a Class II device regulated under 21 CFR 892.2040. Advanced Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1984
Date Received
January 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type