Cleared Special

K092101 - REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES (FDA 510(k) Clearance)

K092101 · Nonin Medical, Inc. · Anesthesiology device

Oct 2009

Decision

99d

Days

Class 2

Risk

K092101 is an FDA 510(k) clearance for the REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES. 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 21, 2009, 99 days after receiving the submission on July 14, 2009.

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

Submission Details

510(k) Number	K092101 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 14, 2009
Decision Date	October 21, 2009
Days to Decision	99 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF