AQUANET, MODEL EC 2000— 510(k) K000031

Name: FDA 510(k) clearance K000031
Creator: U.S. Food and Drug Administration
Published: 2001-09-10

Substantially Equivalent

Prime Pacific Health Innovations Corporation

FDA 510(k) clearance K000031 for AQUANET, MODEL EC 2000, Substantially Equivalent on 2001-09-10. Applicant: Prime Pacific Health Innovations Corporation. Device class: 2.

Clearance details

Applicant: Prime Pacific Health Innovations Corporation
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 2000-01-05
Decision date: 2001-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Vancouver, CA

Download summary PDF View on FDA.gov ↗

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