CORSAIRE— 510(k) K982750

Substantially Equivalent

Optiway, Inc.

FDA 510(k) clearance K982750 for CORSAIRE, Substantially Equivalent on 1999-02-01. Applicant: Optiway, Inc..

Clearance details

Applicant: Optiway, Inc.
Product code: Code ITI
Advisory panel: Physical Medicine
Date received: 1998-08-06
Decision date: 1999-02-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Washington, DC, US

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Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.