Cleared Traditional

K790056 - CANNULAS, DYNACOR'S NASAL OXYGEN (FDA 510(k) Clearance)

Feb 1979
Decision
27d
Days
Class 1
Risk

K790056 is an FDA 510(k) clearance for the CANNULAS, DYNACOR'S NASAL OXYGEN. This device is classified as a Cannula, Nasal, Oxygen (Class I - General Controls, product code CAT).

Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1979, 27 days after receiving the submission on January 9, 1979.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5340.

Submission Details

510(k) Number K790056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1979
Decision Date February 05, 1979
Days to Decision 27 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code CAT — Cannula, Nasal, Oxygen
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5340