Cleared Traditional

K030668 - MODEL 3100 WRISTOX PULSE OXIMETER (FDA 510(k) Clearance)

K030668 · Nonin Medical, Inc. · Anesthesiology device

Oct 2003

Decision

228d

Days

Class 2

Risk

K030668 is an FDA 510(k) clearance for the MODEL 3100 WRISTOX 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 October 17, 2003, 228 days after receiving the submission on March 3, 2003.

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

Submission Details

510(k) Number	K030668 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 03, 2003
Decision Date	October 17, 2003
Days to Decision	228 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF