Cleared Traditional

K771075 - OXYGEN CONNECTING TUBE #017205 (FDA 510(k) Clearance)

Aug 1977
Decision
51d
Days
Class 1
Risk

K771075 is an FDA 510(k) clearance for the OXYGEN CONNECTING TUBE #017205. This device is classified as a Tubing, Pressure And Accessories (Class I - General Controls, product code BYX).

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 868.5860.

Submission Details

510(k) Number K771075 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 BYX — Tubing, Pressure And Accessories
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5860