THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER— 510(k) K901281

Substantially Equivalent

Val-Mark Medical, Inc.

FDA 510(k) clearance K901281 for THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER, Substantially Equivalent on 1991-08-28. Applicant: Val-Mark Medical, Inc..

Clearance details

Applicant: Val-Mark Medical, Inc.
Product code: Code DRB
Advisory panel: Cardiovascular
Date received: 1990-03-19
Decision date: 1991-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West St. Paul, MN, US

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Adverse events under product code DRB

product code DRB

Death: 36
Injury: 562
Total: 598

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.