ANESTHESIA & BRAIN MONITOR— 510(k) K821910

Name: FDA 510(k) clearance K821910
Creator: U.S. Food and Drug Administration
Published: 1982-09-07

Substantially Equivalent

Datex Division Instrumentarium Corp.

FDA 510(k) clearance K821910 for ANESTHESIA & BRAIN MONITOR, Substantially Equivalent on 1982-09-07. Applicant: Datex Division Instrumentarium Corp.. Device class: 2.

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 1982-06-28
Decision date: 1982-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.