2010 PLUS HOLTER FOR WINDOWS— 510(k) K003763

Name: FDA 510(k) clearance K003763
Creator: U.S. Food and Drug Administration
Published: 2001-01-05

Substantially Equivalent

Agilent Technologies

FDA 510(k) clearance K003763 for 2010 PLUS HOLTER FOR WINDOWS, Substantially Equivalent on 2001-01-05. Applicant: Agilent Technologies. Device class: 2.

Clearance details

Applicant: Agilent Technologies
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2000-12-06
Decision date: 2001-01-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Oxnard, CA, US

Download summary PDF View on FDA.gov ↗

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