Cleared Traditional

K023044 - MODEL 9600, AVANT PULSE OXIMETER (FDA 510(k) Clearance)

K023044 · Nonin Medical, Inc. · Anesthesiology device

Jul 2003

Decision

314d

Days

Class 2

Risk

K023044 is an FDA 510(k) clearance for the MODEL 9600, AVANT PULSE OXIMETER. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 23, 2003, 314 days after receiving the submission on September 12, 2002.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K023044 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 12, 2002
Decision Date	July 23, 2003
Days to Decision	314 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF