Cleared Traditional

MASK, GAS, ANESTHETIC

K945894 · Hans Rudolph, Inc. · Anesthesiology
Jan 1995
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K945894 is an FDA 510(k) clearance for the MASK, GAS, ANESTHETIC, a Mask, Gas, Anesthetic (Class I — General Controls, product code BSJ), submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on January 27, 1995, 56 days after receiving the submission on December 2, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5550.

Submission Details

510(k) Number K945894 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1994
Decision Date January 27, 1995
Days to Decision 56 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BSJ — Mask, Gas, Anesthetic
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5550

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