510(k) K811901

CENTURY BATHING SYSTEM by Century Manufacturing Co. — Product Code FNG

K811901 is an FDA 510(k) premarket notification submitted by Century Manufacturing Co. for the device "CENTURY BATHING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 23, 1981. The device falls under product code FNG (Lift, Patient, Ac-Powered), a Class II device regulated under 21 CFR 880.5500. Century Manufacturing Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1981
Date Received
July 1, 1981
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