510(k) K212219
K212219 is an FDA 510(k) premarket notification submitted by Fifth Eye, Inc. for the device "AHI System". The FDA issued a decision of Substantially Equivalent on December 3, 2021. The device falls under product code QNV (Adjunctive Hemodynamic Indicator With Decision Point), a Class II device regulated under 21 CFR 870.2220. Fifth Eye, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2021
- Date Received
- July 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adjunctive Hemodynamic Indicator With Decision Point
- Device Class
- Class II
- Regulation Number
- 870.2220
- Review Panel
- CV
- Submission Type
An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.