DINAMAP VITAL SIGNS MONITOR #1846P— 510(k) K832656

Substantially Equivalent

Critikon Company, LLC

FDA 510(k) clearance K832656 for DINAMAP VITAL SIGNS MONITOR #1846P, Substantially Equivalent on 1983-11-07. Applicant: Critikon Company, LLC.

Clearance details

Applicant: Critikon Company, LLC
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1983-08-08
Decision date: 1983-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.