510(k) K851740

EZZIE SYSTEM by Independent Living, Inc. — Product Code IQA

K851740 is an FDA 510(k) premarket notification submitted by Independent Living, Inc. for the device "EZZIE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 15, 1985. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1985
Date Received
April 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Environmental Control, Powered
Device Class
Class II
Regulation Number
890.3725
Review Panel
PM
Submission Type