TRANSONIC SYSTEMS, INC.

FDA Device Registration & Listing · ITHACA, NY, US · Registration 1319030

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1319030
FEI Number
1319030
Entity Name
TRANSONIC SYSTEMS, INC.
City/State/Country
ITHACA, NY, US
Establishment Address
34 Dutch Mill Rd, ITHACA, NY 14850, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TRANSONIC SYSTEMS, INC. (Owner Number: 1319030)
Owner / Operator Contact Address
34 Dutch Mill Road, Ithaca, NY 14850, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K134051
PMA Number
N/A

All Registered Proprietary Names

HT300 Series Transit Time Flowmeter AureFlo Monitoring System HD02 Hemodialysis Monitor HD01 Hemodialysis Monitor HD03 Hemdialysis Monitor HD02-E Hemodialysis Monitor Transonic ELSA System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2007-12-05
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2011-12-30
MQS System, Hemodialysis, Access Recirculation Monitoring Gastroenterology, Urology Class 2 876.5820 2007-12-05
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2015-02-11

Official Correspondent

Elizabeth Emig-Rosekrans

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TRANSONIC SYSTEMS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903633 Transonic Systems, Inc. ADVANCE LASER FLOWMETER, ALF 21 1990-10-09
K182494 Laser Associated Sciences, Inc. FlowMet-R 2019-02-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1319030. Last updated year: 2026. Please use registration number 1319030 when referencing this establishment in official correspondence.
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