OXYGEN CANNULA— 510(k) K770996

Name: FDA 510(k) clearance K770996
Creator: U.S. Food and Drug Administration
Published: 1977-06-29

Substantially Equivalent

Ohio Medical Products

FDA 510(k) clearance K770996 for OXYGEN CANNULA, Substantially Equivalent on 1977-06-29. Applicant: Ohio Medical Products. Device class: 1.

Clearance details

Applicant: Ohio Medical Products
Product code: Code CAT
Device class: Class 1
Regulation: 21 CFR 868.5340
Advisory panel: Anesthesiology
Date received: 1977-06-01
Decision date: 1977-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K921496 — SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED1992-08-14
K920573 — CANNULA NASAL OXYGEN1992-08-11

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K841274 — BAG-TO-VENTILATOR SELECTOR VALVE1984-04-13
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Adverse events under product code CAT

product code CAT

Death: 5
Malfunction: 544
Other: 2
Total: 551

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.