TONOMETERED SLAINE BLOOD GAS CONTROL— 510(k) K961441

Name: FDA 510(k) clearance K961441
Creator: U.S. Food and Drug Administration
Published: 1996-04-30

Substantially Equivalent

Instrumentarium Corp.

FDA 510(k) clearance K961441 for TONOMETERED SLAINE BLOOD GAS CONTROL, Substantially Equivalent on 1996-04-30. Applicant: Instrumentarium Corp.. Device class: 1.

Clearance details

Applicant: Instrumentarium Corp.
Product code: Code JJS
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1996-04-15
Decision date: 1996-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tewksbury, MA, US

Download summary PDF View on FDA.gov ↗

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