Cleared Traditional

EMIT FREELEVEL SYSTEM I

K820224 · Syva Co. · Chemistry
Feb 1982
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K820224 is an FDA 510(k) clearance for the EMIT FREELEVEL SYSTEM I, a Unit, Filter, Membrane (Class I — General Controls, product code JRL), submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1982, 27 days after receiving the submission on January 27, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K820224 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1982
Decision Date February 23, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JRL — Unit, Filter, Membrane
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050