The following data is part of a premarket notification filed by Neurovision Medical Products, Inc. with the FDA for Neurovision Medical Motion Sensor.
Device ID | K130570 |
510k Number | K130570 |
Device Name: | NEUROVISION MEDICAL MOTION SENSOR |
Classification | Monitor, Breathing Frequency |
Applicant | NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE SUITE 1000 Ventura, CA 93003 |
Contact | Christine Vergely |
Correspondent | Christine Vergely NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE SUITE 1000 Ventura, CA 93003 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-04 |
Decision Date | 2013-12-26 |
Summary: | summary |