510(k) K071793

CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR by Barton Medical Corp. — Product Code INO

K071793 is an FDA 510(k) premarket notification submitted by Barton Medical Corp. for the device "CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR". The FDA issued a decision of Substantially Equivalent on August 3, 2007. 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
August 3, 2007
Date Received
July 2, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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