NORMCAP CD-102, CARBON DIOXIDE ANALYZER— 510(k) K801083

Substantially Equivalent

Instrumentarium-Datex

FDA 510(k) clearance K801083 for NORMCAP CD-102, CARBON DIOXIDE ANALYZER, Substantially Equivalent on 1980-05-28. Applicant: Instrumentarium-Datex.

Clearance details

Applicant: Instrumentarium-Datex
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 1980-05-07
Decision date: 1980-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CCL

product code CCL

Other: 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.