510(k) K874750

VIDEO ANALYZER 4000 by Scientific Imaging, Inc. — Product Code IBJ

K874750 is an FDA 510(k) premarket notification submitted by Scientific Imaging, Inc. for the device "VIDEO ANALYZER 4000". The FDA issued a decision of Substantially Equivalent on April 25, 1988. The device falls under product code IBJ (Light, Microscope), a Class I device regulated under 21 CFR 864.3600. Scientific Imaging, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1988
Date Received
November 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Microscope
Device Class
Class I
Regulation Number
864.3600
Review Panel
PA
Submission Type