Cleared Traditional

K101539 - VITAL SIGNS MONITOR MODEL M3B (FDA 510(k) Clearance)

K101539 · Edan Instruments, Inc. · Anesthesiology device

Nov 2010

Decision

174d

Days

Class 2

Risk

K101539 is an FDA 510(k) clearance for the VITAL SIGNS MONITOR MODEL M3B. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Edan Instruments, Inc. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on November 24, 2010, 174 days after receiving the submission on June 3, 2010.

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

Submission Details

510(k) Number	K101539 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 03, 2010
Decision Date	November 24, 2010
Days to Decision	174 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF