Cleared Traditional

AAP DOSIMETRY RELEASE OR BASIN SETS

K832826 · American Hospital Supply Corp. · General Hospital
Apr 1984
Decision
248d
Days
Class 1
Risk

About This 510(k) Submission

K832826 is an FDA 510(k) clearance for the AAP DOSIMETRY RELEASE OR BASIN SETS, a Basin, Emesis (Class I — General Controls, product code FNY), submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984, 248 days after receiving the submission on August 19, 1983. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6730.

Submission Details

510(k) Number K832826 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1983
Decision Date April 23, 1984
Days to Decision 248 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FNY — Basin, Emesis
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6730