Cleared Traditional

JEMSDAL MASK

K942907 · Respan Products, Inc. · Anesthesiology

Aug 1994

Decision

71d

Days

Class 1

Risk

About This 510(k) Submission

K942907 is an FDA 510(k) clearance for the JEMSDAL MASK, a Mask, Oxygen (Class I — General Controls, product code BYG), submitted by Respan Products, Inc. (Lewiston, US). The FDA issued a Cleared decision on August 31, 1994, 71 days after receiving the submission on June 21, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number	K942907 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 1994
Decision Date	August 31, 1994
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement