Cleared Traditional

WARM N WET HMEF W/LUER ADAPTER

K953620 · Hospitak, Inc. · Anesthesiology

Aug 1995

Decision

22d

Days

Class 1

Risk

About This 510(k) Submission

K953620 is an FDA 510(k) clearance for the WARM N WET HMEF W/LUER ADAPTER, a Condenser, Heat And Moisture (artificial Nose) (Class I — General Controls, product code BYD), submitted by Hospitak, Inc. (Farmingdale, US). The FDA issued a Cleared decision on August 25, 1995, 22 days after receiving the submission on August 3, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number	K953620 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 1995
Decision Date	August 25, 1995
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF