Cleared Traditional

K791705 - 4200 PNEUMATIC MOUTH SHUTTER
(FDA 510(k) Clearance)

K791705 · Hans Rudolph, Inc. · Anesthesiology device

Oct 1979

Decision

37d

Days

Class 2

Risk

K791705 is an FDA 510(k) clearance for the 4200 PNEUMATIC MOUTH SHUTTER. This device is classified as a Plethysmograph, Pressure (Class II - Special Controls, product code CCM).

Submitted by Hans Rudolph, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1979, 37 days after receiving the submission on August 28, 1979.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1750.

Submission Details

510(k) Number	K791705 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 28, 1979
Decision Date	October 04, 1979
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—