FLEXVIEW CLINICAL MONITORING SYSTEM— 510(k) K003998

Name: FDA 510(k) clearance K003998
Creator: U.S. Food and Drug Administration
Published: 2001-03-07

Substantially Equivalent

Data Critical Corp.

FDA 510(k) clearance K003998 for FLEXVIEW CLINICAL MONITORING SYSTEM, Substantially Equivalent on 2001-03-07. Applicant: Data Critical Corp.. Device class: 2.

Clearance details

Applicant: Data Critical Corp.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2000-12-26
Decision date: 2001-03-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Data Critical Corp.

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K013156 — MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM2001-10-19
K011999 — MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM2001-07-24
K012005 — MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM2001-07-24
K010912 — ALARMVIEW WIRELESS DATA NETWORK SYSTEM2001-04-05
K992848 — ALARMVIEW SYSTEM1999-11-19

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.