INTELLIFLOW RESPIRATORY ANALYZER— 510(k) K970840

Substantially Equivalent

Simtec, Inc.

FDA 510(k) clearance K970840 for INTELLIFLOW RESPIRATORY ANALYZER, Substantially Equivalent on 1997-11-26. Applicant: Simtec, Inc.. Device class: 2.

Clearance details

Applicant: Simtec, Inc.
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 1997-03-07
Decision date: 1997-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marion, SC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.