SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM— 510(k) K070795

Name: FDA 510(k) clearance K070795
Creator: U.S. Food and Drug Administration
Published: 2007-08-31

Substantially Equivalent

Atcor Medical Pty, Ltd.

FDA 510(k) clearance K070795 for SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM, Substantially Equivalent on 2007-08-31. Applicant: Atcor Medical Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Atcor Medical Pty, Ltd.
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 2007-03-22
Decision date: 2007-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

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