Cleared Traditional

K954787 - ILLUMINATOR
(FDA 510(k) Clearance)

K954787 · Hospitak, Inc. · Anesthesiology

Jan 1996

Decision

105d

Days

Class 1

Risk

K954787 is an FDA 510(k) clearance for the ILLUMINATOR, a Laryngoscope, Rigid (Class I — General Controls, product code CCW), submitted by Hospitak, Inc. (Farmingdale, US). The FDA issued a Cleared decision on January 31, 1996, 105 days after receiving the submission on October 18, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5540.

Submission Details

510(k) Number	K954787 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 1995
Decision Date	January 31, 1996
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF