507EL VITAL SIGNS MONITOR— 510(k) K022435

Substantially Equivalent

Criticare Systems, Inc.

FDA 510(k) clearance K022435 for 507EL VITAL SIGNS MONITOR, Substantially Equivalent on 2002-08-14. Applicant: Criticare Systems, Inc..

Clearance details

Applicant: Criticare Systems, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2002-07-25
Decision date: 2002-08-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.