510(k) K862146

BOMDAL TRAVELMASTER LIFT by Bomdal Medical Equipment, Inc. — Product Code FNG

K862146 is an FDA 510(k) premarket notification submitted by Bomdal Medical Equipment, Inc. for the device "BOMDAL TRAVELMASTER LIFT". The FDA issued a decision of Substantially Equivalent on July 15, 1986. The device falls under product code FNG (Lift, Patient, Ac-Powered), a Class II device regulated under 21 CFR 880.5500. Bomdal Medical Equipment, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1986
Date Received
June 4, 1986
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