Cleared Traditional

TYPE 1 & 2 (HUMIDAIR I & II)

K953507 · Icor AB · Anesthesiology
Sep 1995
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K953507 is an FDA 510(k) clearance for the TYPE 1 & 2 (HUMIDAIR I & II), a Condenser, Heat And Moisture (artificial Nose) (Class I — General Controls, product code BYD), submitted by Icor AB (Bromma, SE). The FDA issued a Cleared decision on September 7, 1995, 43 days after receiving the submission on July 26, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number K953507 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1995
Decision Date September 07, 1995
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BYD — Condenser, Heat And Moisture (artificial Nose)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5375