Cleared Traditional

HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)

K960817 · Transonic Systems, Inc. · Gastroenterology & Urology
Feb 1997
Decision
349d
Days
Class 2
Risk

About This 510(k) Submission

K960817 is an FDA 510(k) clearance for the HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2), a System, Hemodialysis, Access Recirculation Monitoring (Class II — Special Controls, product code MQS), submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on February 11, 1997, 349 days after receiving the submission on February 28, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K960817 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 1996
Decision Date February 11, 1997
Days to Decision 349 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MQS — System, Hemodialysis, Access Recirculation Monitoring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820