510(k) K183282
K183282 is an FDA 510(k) premarket notification submitted by Biofourmis Singapore Pte., Ltd. for the device "Biovitals Analytics Engine". The FDA issued a decision of Substantially Equivalent on August 15, 2019. The device falls under product code PLB (Multivariate Vital Signs Index), a Class II device regulated under 21 CFR 870.2300. Biofourmis Singapore Pte., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2019
- Date Received
- November 26, 2018
- 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.