Cleared Traditional

K103584 - ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS (FDA 510(k) Clearance)

K103584 · Shenzhen Envisen Industry Co. Limited · Anesthesiology device

Jun 2011

Decision

185d

Days

Class 2

Risk

K103584 is an FDA 510(k) clearance for the ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Shenzhen Envisen Industry Co. Limited (Egale, US). The FDA issued a Cleared decision on June 10, 2011, 185 days after receiving the submission on December 7, 2010.

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

Submission Details

510(k) Number	K103584 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 07, 2010
Decision Date	June 10, 2011
Days to Decision	185 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF