FLOWMETER, OPTIFLO GAS— 510(k) K790546

Name: FDA 510(k) clearance K790546
Creator: U.S. Food and Drug Administration
Published: 1979-05-11

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K790546 for FLOWMETER, OPTIFLO GAS, Substantially Equivalent on 1979-05-11. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code DTX
Device class: Class 2
Regulation: 21 CFR 870.4300
Advisory panel: Cardiovascular
Date received: 1979-03-20
Decision date: 1979-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTX

product code DTX

Death: 3
Malfunction: 497
Total: 500

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.