Cleared Traditional

TRANSONIC FLOW-QC SET MODEL ADT1010

K021571 · Transonic Systems, Inc. · Gastroenterology & Urology

Aug 2002

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K021571 is an FDA 510(k) clearance for the TRANSONIC FLOW-QC SET MODEL ADT1010, 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 August 12, 2002, 90 days after receiving the submission on May 14, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K021571 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2002
Decision Date	August 12, 2002
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF