Cleared Traditional

K892406 - MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA
(FDA 510(k) Clearance)

K892406 · Salter Labs · Anesthesiology

Jul 1989

Decision

108d

Days

Class 2

Risk

K892406 is an FDA 510(k) clearance for the MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on July 24, 1989, 108 days after receiving the submission on April 7, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number	K892406 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 1989
Decision Date	July 24, 1989
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—