MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM— 510(k) K080670

Name: FDA 510(k) clearance K080670
Creator: U.S. Food and Drug Administration
Published: 2008-04-23

Substantially Equivalent

Atcor Medical

FDA 510(k) clearance K080670 for MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM, Substantially Equivalent on 2008-04-23. Applicant: Atcor Medical. Device class: 2.

Clearance details

Applicant: Atcor Medical
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 2008-03-10
Decision date: 2008-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: West Ryde Nsw, AU

Download summary PDF View on FDA.gov ↗

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