DELTATRAC(TM) METABOLIC MONITOR— 510(k) K864603

Name: FDA 510(k) clearance K864603
Creator: U.S. Food and Drug Administration
Published: 1987-03-17

Substantially Equivalent

Datex Division Instrumentarium Corp.

FDA 510(k) clearance K864603 for DELTATRAC(TM) METABOLIC MONITOR, Substantially Equivalent on 1987-03-17. Applicant: Datex Division Instrumentarium Corp.. Device class: 2.

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Code BZL
Device class: Class 2
Regulation: 21 CFR 868.1730
Advisory panel: Anesthesiology
Date received: 1986-11-24
Decision date: 1987-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melrose, MA, US

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