DeviceClearance

MODEL TPC-1 OXYGEN ANALYZER— 510(k) K821392

Substantially Equivalent

Marathon

FDA 510(k) clearance K821392 for MODEL TPC-1 OXYGEN ANALYZER, Substantially Equivalent on 1982-07-08. Applicant: Marathon. Device class: 2.

Clearance details

Applicant
Marathon
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
Traditional
Location
Mchenry, IL, 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.