K170506

Substantially Equivalent

ECG Check - Universal, ECG Check - Universal Plus

Applicant: Cardiac Designs, Inc.
Product code: DXH
Advisory panel: Cardiovascular
Date received: 2017-02-21
Decision date: 2017-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spring, TX, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.