COMBINED PHYSIOLOGICAL MONITORING SYSTEM— 510(k) K002104

Name: FDA 510(k) clearance K002104
Creator: U.S. Food and Drug Administration
Published: 2000-10-10

Substantially Equivalent

Maryrose Cusimano, Ph.D. & Scott Zeff

FDA 510(k) clearance K002104 for COMBINED PHYSIOLOGICAL MONITORING SYSTEM, Substantially Equivalent on 2000-10-10. Applicant: Maryrose Cusimano, Ph.D. & Scott Zeff. Device class: 2.

Clearance details

Applicant: Maryrose Cusimano, Ph.D. & Scott Zeff
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 2000-07-12
Decision date: 2000-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Lauderdale, FL, 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.