MODEL 405T WITH ETCO2 OPTION— 510(k) K964961

Substantially Equivalent

Ivy Biomedical Systems, Inc.

FDA 510(k) clearance K964961 for MODEL 405T WITH ETCO2 OPTION, Substantially Equivalent on 1997-05-14. Applicant: Ivy Biomedical Systems, Inc..

Clearance details

Applicant: Ivy Biomedical Systems, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1996-12-11
Decision date: 1997-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

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Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.