CRITERION II RHYTHM PROFILE MONITOR— 510(k) K803315

Name: FDA 510(k) clearance K803315
Creator: U.S. Food and Drug Administration
Published: 1981-01-22

Substantially Equivalent

Dart Medical Equipment

FDA 510(k) clearance K803315 for CRITERION II RHYTHM PROFILE MONITOR, Substantially Equivalent on 1981-01-22. Applicant: Dart Medical Equipment. Device class: 2.

Clearance details

Applicant: Dart Medical Equipment
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 1980-12-30
Decision date: 1981-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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