MaxO2ME— 510(k) K153659

Substantially Equivalent

Maxtec, LLC

FDA 510(k) clearance K153659 for MaxO2ME, Substantially Equivalent on 2016-06-10. Applicant: Maxtec, LLC.

Clearance details

Applicant: Maxtec, LLC
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 2015-12-21
Decision date: 2016-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCL

product code CCL

Other: 2
Total: 2

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.