Cleared Traditional

TONOMETERED SLAINE BLOOD GAS CONTROL

K961441 · Instrumentarium Corp. · Chemistry
Apr 1996
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K961441 is an FDA 510(k) clearance for the TONOMETERED SLAINE BLOOD GAS CONTROL, a Controls For Blood-gases, (assayed And Unassayed) (Class I — General Controls, product code JJS), submitted by Instrumentarium Corp. (Tewksbury, US). The FDA issued a Cleared decision on April 30, 1996, 15 days after receiving the submission on April 15, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K961441 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1996
Decision Date April 30, 1996
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJS — Controls For Blood-gases, (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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