Cleared Traditional

WESCOR 5500 VAPOR PRESSURE OSMOMETER

K834214 · Wescor, Inc. · Chemistry
Mar 1984
Decision
116d
Days
Class 1
Risk

About This 510(k) Submission

K834214 is an FDA 510(k) clearance for the WESCOR 5500 VAPOR PRESSURE OSMOMETER, a Osmometer For Clinical Use (Class I — General Controls, product code JJM), submitted by Wescor, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1984, 116 days after receiving the submission on December 5, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2730.

Submission Details

510(k) Number K834214 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 1983
Decision Date March 30, 1984
Days to Decision 116 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJM — Osmometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2730

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