SPHYGMOCOR MX MODEL SCOR-MX— 510(k) K002742

Name: FDA 510(k) clearance K002742
Creator: U.S. Food and Drug Administration
Published: 2001-05-01

Substantially Equivalent

Pwv Medical Pty, Lt.

FDA 510(k) clearance K002742 for SPHYGMOCOR MX MODEL SCOR-MX, Substantially Equivalent on 2001-05-01. Applicant: Pwv Medical Pty, Lt.. Device class: 2.

Clearance details

Applicant: Pwv Medical Pty, Lt.
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 2000-09-01
Decision date: 2001-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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