Cleared Traditional

K873614 - CBG CUFF MANOMETER
(FDA 510(k) Clearance)

K873614 · Bio-Med Devices, Inc. · Anesthesiology device

Jan 1988

Decision

136d

Days

Class 2

Risk

K873614 is an FDA 510(k) clearance for the CBG CUFF MANOMETER. This device is classified as a Cuff, Tracheal Tube, Inflatable (Class II - Special Controls, product code BSK).

Submitted by Bio-Med Devices, Inc. (Madison, US). The FDA issued a Cleared decision on January 22, 1988, 136 days after receiving the submission on September 8, 1987.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number	K873614 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 08, 1987
Decision Date	January 22, 1988
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—