Cleared Traditional

K951652 - VENTIMASK MK IV
(FDA 510(k) Clearance)

K951652 · Flexicare Medical, Ltd. · Anesthesiology

Apr 1995

Decision

17d

Days

Class 1

Risk

K951652 is an FDA 510(k) clearance for the VENTIMASK MK IV, a Mask, Oxygen, Low Concentration, Venturi (Class I — General Controls, product code BYF), submitted by Flexicare Medical, Ltd. (Somerset, GB). The FDA issued a Cleared decision on April 27, 1995, 17 days after receiving the submission on April 10, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5600.

Submission Details

510(k) Number	K951652 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 1995
Decision Date	April 27, 1995
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement