510(k) K142512
K142512 is an FDA 510(k) premarket notification submitted by Vgbio, Inc (Dba Physiq) for the device "Personalized Physiology Analytics Engine software". The FDA issued a decision of Substantially Equivalent on June 11, 2015. The device falls under product code PLB (Multivariate Vital Signs Index), a Class II device regulated under 21 CFR 870.2300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2015
- Date Received
- September 8, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multivariate Vital Signs Index
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type
Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.