MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM— 510(k) K011999

Substantially Equivalent

Data Critical Corp.

FDA 510(k) clearance K011999 for MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM, Substantially Equivalent on 2001-07-24. Applicant: Data Critical Corp..

Clearance details

Applicant: Data Critical Corp.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2001-06-27
Decision date: 2001-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Bothell, WA, US

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.