Cleared Traditional

DELTATRAC(TM) II METABOLIC MONITOR

K931422 · Datex Division Instrumentarium Corp. · Anesthesiology

Nov 1993

Decision

247d

Days

Class 2

Risk

About This 510(k) Submission

K931422 is an FDA 510(k) clearance for the DELTATRAC(TM) II METABOLIC MONITOR, a Computer, Oxygen-uptake (Class II — Special Controls, product code BZL), submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on November 24, 1993, 247 days after receiving the submission on March 22, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1730.

Submission Details

510(k) Number	K931422 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 1993
Decision Date	November 24, 1993
Days to Decision	247 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement