CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M— 510(k) K061112

Substantially Equivalent

Conmed Corporation

FDA 510(k) clearance K061112 for CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M, Substantially Equivalent on 2006-05-22. Applicant: Conmed Corporation.

Clearance details

Applicant: Conmed Corporation
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2006-04-21
Decision date: 2006-05-22
Decision: Substantially Equivalent
Clearance type: Special
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.