Cleared Traditional

K041156 - AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 (FDA 510(k) Clearance)

K041156 · Nonin Medical, Inc. · Anesthesiology device

Jun 2004

Decision

37d

Days

Class 2

Risk

K041156 is an FDA 510(k) clearance for the AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001. 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 June 9, 2004, 37 days after receiving the submission on May 3, 2004.

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

Submission Details

510(k) Number	K041156 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 03, 2004
Decision Date	June 09, 2004
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF