Cleared Traditional

WESTMED RESPIRATORY LUER ADAPTOR

K953506 · Westmed Intl. · Anesthesiology
Sep 1995
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K953506 is an FDA 510(k) clearance for the WESTMED RESPIRATORY LUER ADAPTOR, a Flowmeter, Calibration, Gas (Class I — General Controls, product code BXY), submitted by Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on September 15, 1995, 51 days after receiving the submission on July 26, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2350.

Submission Details

510(k) Number K953506 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1995
Decision Date September 15, 1995
Days to Decision 51 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BXY — Flowmeter, Calibration, Gas
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.2350