Cleared Traditional

DANNINFLEX CPM 800

K923216 · Buckman Co., Inc. · Physical Medicine
Aug 1992
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K923216 is an FDA 510(k) clearance for the DANNINFLEX CPM 800, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on August 3, 1992, 33 days after receiving the submission on July 1, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number K923216 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1992
Decision Date August 03, 1992
Days to Decision 33 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code BXB — Exerciser, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5380