Cleared Traditional

K130570 - NEUROVISION MEDICAL MOTION SENSOR
(FDA 510(k) Clearance)

K130570 · Neurovision Medical Products, Inc. · Anesthesiology

Dec 2013

Decision

297d

Days

Class 2

Risk

K130570 is an FDA 510(k) clearance for the NEUROVISION MEDICAL MOTION SENSOR, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Neurovision Medical Products, Inc. (Ventura, US). The FDA issued a Cleared decision on December 26, 2013, 297 days after receiving the submission on March 4, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number	K130570 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2013
Decision Date	December 26, 2013
Days to Decision	297 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF