CAPNOMAC ULTIMA ANESTHESIA MONITOR— 510(k) K932098

Substantially Equivalent

Datex Division Instrumentarium Corp.

FDA 510(k) clearance K932098 for CAPNOMAC ULTIMA ANESTHESIA MONITOR, Substantially Equivalent on 1993-11-29. Applicant: Datex Division Instrumentarium Corp..

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 1993-05-03
Decision date: 1993-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, Finland, FI

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Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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