Cleared Traditional

K142832 - Unimed Disposable and Reusable SPO2 Sensors (FDA 510(k) Clearance)

K142832 · Unimed Medical Supplies, Inc. · Anesthesiology device

Feb 2015

Decision

129d

Days

Class 2

Risk

K142832 is an FDA 510(k) clearance for the Unimed Disposable and Reusable SPO2 Sensors. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on February 6, 2015, 129 days after receiving the submission on September 30, 2014.

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

Submission Details

510(k) Number	K142832 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 30, 2014
Decision Date	February 06, 2015
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF