510(k) K140852
K140852 is an FDA 510(k) premarket notification submitted by Vectracor, Inc. for the device "VECTRAPLEX CMS". The FDA issued a decision of Substantially Equivalent on Jan 30, 2015. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Vectracor, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 30, 2015
- Date Received
- Apr 3, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type
- 510(k)