510(k) K923159

ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS by Arjo-Century, Inc. — Product Code ILJ

K923159 is an FDA 510(k) premarket notification submitted by Arjo-Century, Inc. for the device "ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS". The FDA issued a decision of Substantially Equivalent on August 6, 1992. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100. Arjo-Century, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1992
Date Received
June 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Hydro-Massage
Device Class
Class II
Regulation Number
890.5100
Review Panel
PM
Submission Type