Oxitone 1000— 510(k) K163382

Substantially Equivalent

Oxitone Medical , Ltd.

FDA 510(k) clearance K163382 for Oxitone 1000, Substantially Equivalent on 2017-05-09. Applicant: Oxitone Medical , Ltd..

Clearance details

Applicant: Oxitone Medical , Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2016-12-01
Decision date: 2017-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

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.