DINAMAP MPS SELECT PORTABLE MONITOR— 510(k) K982342

Substantially Equivalent

Critikon Company, LLC

FDA 510(k) clearance K982342 for DINAMAP MPS SELECT PORTABLE MONITOR, Substantially Equivalent on 1998-08-14. Applicant: Critikon Company, LLC.

Clearance details

Applicant: Critikon Company, LLC
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 1998-07-06
Decision date: 1998-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

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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.