Cleared Traditional

FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE

K952823 · Icor AB · Anesthesiology

Jul 1995

Decision

23d

Days

Class 1

Risk

About This 510(k) Submission

K952823 is an FDA 510(k) clearance for the FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE, 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 July 13, 1995, 23 days after receiving the submission on June 20, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number	K952823 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 1995
Decision Date	July 13, 1995
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement