DeviceClearance

ULTRAMAXO2 OXYGEN ANALYER— 510(k) K112402

Substantially Equivalent

Maxtec, LLC

FDA 510(k) clearance K112402 for ULTRAMAXO2 OXYGEN ANALYER, Substantially Equivalent on 2011-12-14. Applicant: Maxtec, LLC. Device class: 2.

Clearance details

Applicant
Maxtec, LLC
Product code
Code CCL
Device class
Class 2
Regulation
21 CFR 868.1720
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Salt Lake City, UT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CCL

product code CCL
Other
2
Total
2

Source: openFDA MAUDE database, through . 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.