Cleared Traditional

K052669 - AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 (FDA 510(k) Clearance)

K052669 · Nonin Medical, Inc. · Anesthesiology device

Dec 2005

Decision

87d

Days

Class 2

Risk

K052669 is an FDA 510(k) clearance for the AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100. 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 December 23, 2005, 87 days after receiving the submission on September 27, 2005.

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

Submission Details

510(k) Number	K052669 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 27, 2005
Decision Date	December 23, 2005
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF