CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO— 510(k) K931968

Name: FDA 510(k) clearance K931968
Creator: U.S. Food and Drug Administration
Published: 1993-11-10

Substantially Equivalent

3M Health Care, Ltd.

FDA 510(k) clearance K931968 for CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO, Substantially Equivalent on 1993-11-10. Applicant: 3M Health Care, Ltd.. Device class: 2.

Clearance details

Applicant: 3M Health Care, Ltd.
Product code: Code DRY
Device class: Class 2
Regulation: 21 CFR 870.4330
Advisory panel: Cardiovascular
Date received: 1993-04-21
Decision date: 1993-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.