510(k) K031045

AEROLET TOILET LIFT, MODEL AER-01 by Economic Holland B.V. — Product Code INO

K031045 is an FDA 510(k) premarket notification submitted by Economic Holland B.V. for the device "AEROLET TOILET LIFT, MODEL AER-01". The FDA issued a decision of Substantially Equivalent on July 10, 2003. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2003
Date Received
April 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Positioning, Electric
Device Class
Class II
Regulation Number
890.3110
Review Panel
PM
Submission Type