510(k) K926411

SAF-LIFT/SAF-KARY by Arjo-Century, Inc. — Product Code FNG

K926411 is an FDA 510(k) premarket notification submitted by Arjo-Century, Inc. for the device "SAF-LIFT/SAF-KARY". The FDA issued a decision of Substantially Equivalent on March 31, 1993. The device falls under product code FNG (Lift, Patient, Ac-Powered), a Class II device regulated under 21 CFR 880.5500. Arjo-Century, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1993
Date Received
December 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lift, Patient, Ac-Powered
Device Class
Class II
Regulation Number
880.5500
Review Panel
HO
Submission Type