MAXO2 CU— 510(k) K063488

Substantially Equivalent

Maxtec, Inc.

FDA 510(k) clearance K063488 for MAXO2 CU, Substantially Equivalent on 2007-02-22. Applicant: Maxtec, Inc..

Clearance details

Applicant: Maxtec, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 2006-11-17
Decision date: 2007-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

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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.