FREEDOM OXIMETER/EEG DIGITAL INTERFACE— 510(k) K924752

Substantially Equivalent

Pro-Tech, Inc.

FDA 510(k) clearance K924752 for FREEDOM OXIMETER/EEG DIGITAL INTERFACE, Substantially Equivalent on 1993-09-10. Applicant: Pro-Tech, Inc..

Clearance details

Applicant: Pro-Tech, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1992-09-23
Decision date: 1993-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodinville, WA, US

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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.