DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER— 510(k) K874442

Substantially Equivalent

Critikon Company, LLC

FDA 510(k) clearance K874442 for DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER, Substantially Equivalent on 1988-02-18. Applicant: Critikon Company, LLC.

Clearance details

Applicant: Critikon Company, LLC
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1987-10-28
Decision date: 1988-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.