Assurance Alar / Nasal SpO2 Sensor— 510(k) K143216

Substantially Equivalent

Xhale, Inc.

FDA 510(k) clearance K143216 for Assurance Alar / Nasal SpO2 Sensor, Substantially Equivalent on 2015-03-17. Applicant: Xhale, Inc..

Clearance details

Applicant: Xhale, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2014-11-10
Decision date: 2015-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, 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.