510(k) K213255

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

June 17, 2022

Date Received

September 30, 2021

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Adjunctive Cardiovascular Status Indicator

Device Class

Class II

Regulation Number

870.2200

Review Panel

CV

Submission Type

The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.