VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR— 510(k) K955816

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K955816 for VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR, Substantially Equivalent on 1997-05-06. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1995-12-26
Decision date: 1997-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.