510(k) K905414

MANGAR BOOSTER by Northfleet Management Group, Inc. — Product Code FNG

K905414 is an FDA 510(k) premarket notification submitted by Northfleet Management Group, Inc. for the device "MANGAR BOOSTER". The FDA issued a decision of Substantially Equivalent on March 5, 1991. The device falls under product code FNG (Lift, Patient, Ac-Powered), a Class II device regulated under 21 CFR 880.5500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1991
Date Received
December 3, 1990
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