Cleared Traditional

K052829 - WRISTOX MODEL 3100 PULSE OXIMETER (FDA 510(k) Clearance)

K052829 · Nonin Medical, Inc. · Anesthesiology device

Nov 2005

Decision

36d

Days

Class 2

Risk

K052829 is an FDA 510(k) clearance for the WRISTOX MODEL 3100 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 November 10, 2005, 36 days after receiving the submission on October 5, 2005.

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

Submission Details

510(k) Number	K052829 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 05, 2005
Decision Date	November 10, 2005
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF