Cleared Traditional

K964399 - DALE ENDOTRACHEAL TUBE HOLDER 270/280
(FDA 510(k) Clearance)

K964399 · Dale Medical Products, Inc. · Anesthesiology

Jan 1997

Decision

85d

Days

Class 1

Risk

K964399 is an FDA 510(k) clearance for the DALE ENDOTRACHEAL TUBE HOLDER 270/280. This device is classified as a Device, Fixation, Tracheal Tube (Class I — General Controls, product code CBH).

Submitted by Dale Medical Products, Inc. (Plainville, US). The FDA issued a Cleared decision on January 28, 1997, 85 days after receiving the submission on November 4, 1996.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5770.

Submission Details

510(k) Number	K964399 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 1996
Decision Date	January 28, 1997
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement