506CN PATIENT MONITOR— 510(k) K091050

Substantially Equivalent

Criticare Systems, Inc.

FDA 510(k) clearance K091050 for 506CN PATIENT MONITOR, Substantially Equivalent on 2009-05-27. Applicant: Criticare Systems, Inc..

Clearance details

Applicant: Criticare Systems, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2009-04-13
Decision date: 2009-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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.