510(k) K130570
K130570 is an FDA 510(k) premarket notification submitted by Neurovision Medical Products, Inc. for the device "NEUROVISION MEDICAL MOTION SENSOR". The FDA issued a decision of Substantially Equivalent on December 26, 2013. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Neurovision Medical Products, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 26, 2013
- Date Received
- March 4, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Breathing Frequency
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type