Cleared Traditional

WHIRLPOOL AERATOR WB700, WB800, WB900, WB975

K872327 · Associated Mills, Inc. · Physical Medicine
Sep 1987
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K872327 is an FDA 510(k) clearance for the WHIRLPOOL AERATOR WB700, WB800, WB900, WB975, a Bath, Hydro-massage (Class II — Special Controls, product code ILJ), submitted by Associated Mills, Inc. (Chicago, US). The FDA issued a Cleared decision on September 4, 1987, 79 days after receiving the submission on June 17, 1987. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5100.

Submission Details

510(k) Number K872327 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1987
Decision Date September 04, 1987
Days to Decision 79 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code ILJ — Bath, Hydro-massage
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5100