510(k) K823608

PICTURES & WORD IDENTIFICATION CVA PAT by Fred Sammons, Inc. — Product Code ILP

K823608 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "PICTURES & WORD IDENTIFICATION CVA PAT". The FDA issued a decision of Substantially Equivalent on December 30, 1982. The device falls under product code ILP (System, Communication, Non-Powered), a Class I device regulated under 21 CFR 890.3700. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1982
Date Received
December 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Communication, Non-Powered
Device Class
Class I
Regulation Number
890.3700
Review Panel
PM
Submission Type