A-V IMPULSE SYSTEM— 510(k) K914461

Substantially Equivalent

Novamedix , Ltd.

FDA 510(k) clearance K914461 for A-V IMPULSE SYSTEM, Substantially Equivalent on 1992-04-15. Applicant: Novamedix , Ltd.. Device class: 2.

Clearance details

Applicant: Novamedix , Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 1991-10-07
Decision date: 1992-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.