PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200— 510(k) K032831

Substantially Equivalent

Conmed Corporation

FDA 510(k) clearance K032831 for PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200, Substantially Equivalent on 2004-08-31. Applicant: Conmed Corporation.

Clearance details

Applicant: Conmed Corporation
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2003-09-11
Decision date: 2004-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utica, NY, US

Download summary PDF View on FDA.gov ↗

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.