Cleared Traditional

CAPNOMAC ULTIMA ANESTHESIA MONITOR

K932098 · Datex Division Instrumentarium Corp. · Anesthesiology

Nov 1993

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K932098 is an FDA 510(k) clearance for the CAPNOMAC ULTIMA ANESTHESIA MONITOR, a Spirometer, Monitoring (w/wo Alarm) (Class II — Special Controls, product code BZK), submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on November 29, 1993, 210 days after receiving the submission on May 3, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1850.

Submission Details

510(k) Number	K932098 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 1993
Decision Date	November 29, 1993
Days to Decision	210 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement