HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)— 510(k) K960817

Name: FDA 510(k) clearance K960817
Creator: U.S. Food and Drug Administration
Published: 1997-02-11

Substantially Equivalent

Transonic Systems, Inc.

FDA 510(k) clearance K960817 for HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2), Substantially Equivalent on 1997-02-11. Applicant: Transonic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Transonic Systems, Inc.
Product code: Code MQS
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1996-02-28
Decision date: 1997-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ithaca, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K960817

K-number listed on FDA's recall record

Z-1295-2015 — Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.Class II·Terminated·Transonic Systems Inc·20150217

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960817.

Data sourced from openFDA. This site is unofficial and independent of the FDA.