Cleared Traditional

K771074 - NASAL OXYGEN CANNULA, #017207 (FDA 510(k) Clearance)

Aug 1977
Decision
51d
Days
Class 1
Risk

K771074 is an FDA 510(k) clearance for the NASAL OXYGEN CANNULA, #017207. This device is classified as a Cannula, Nasal, Oxygen (Class I - General Controls, product code CAT).

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1977, 51 days after receiving the submission on June 14, 1977.

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

Submission Details

510(k) Number K771074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1977
Decision Date August 04, 1977
Days to Decision 51 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