510(k) K231335

Device

Cleerly ISCHEMIA

Applicant

Cleerly, Inc.

510(k) number

K231335

Product code

QXZ

Decision

Substantially Equivalent (SESE)

Decision date

2023-09-08

Date received

2023-05-08

Regulation

870.2200

Classification name

Adjunctive Epicardial Vascular Physiologic Status Indicator

Medical specialty

Cardiovascular

Review panel

Cardiovascular

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No