INTRICON CORPORATION

FDA Device Registration & Listing · ARDEN HILLS, MN, US · Registration 2134850

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
2134850
FEI Number
3003007876
Entity Name
INTRICON CORPORATION
City/State/Country
ARDEN HILLS, MN, US
Establishment Address
1260 Red Fox Rd, ARDEN HILLS, MN 55112, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
INTRICON CORPORATION (Owner Number: 9039676)
Owner / Operator Contact Address
1265 Grey Fox Road, --, Saint Paul, MN 55112, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P980022

All Registered Proprietary Names

Percutaneous Biopsy Needle Electromagnetic Tracker

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-02-10
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-02-10
PKU Insulin Pump Secondary Display Clinical Chemistry Class 2 862.1350 2015-12-10
PJT Continuous Glucose Monitor Secondary Display Clinical Chemistry Class 2 862.1350 2015-12-10
OZP Automated Insulin Dosing Device System, Single Hormonal Control Unknown Class 3 N/A 2019-11-22
OZO Automated Insulin Dosing , Threshold Suspend Unknown Class 3 N/A 2017-01-23
MDS Sensor, Glucose, Invasive Unknown Class 3 N/A 2020-05-08
MDS Sensor, Glucose, Invasive Unknown Class 3 N/A 2017-01-23
MDS Sensor, Glucose, Invasive Unknown Class 3 N/A 2013-01-11
OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor Unknown Class 3 N/A 2013-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INTRICON CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014498598 IntriCon Corporation Grey Fox Arden Hills, MN, US
3007939342 IntriCon Corporation VH Vadnais Heights, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243523 Siemens Medical Solutions USA, Inc. NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime 2025-02-12
K781431 General Electric Co. ELECTRIC CT/T OPERATOR DISPLAY CONSOLE 1978-09-07
K231574 FUJIFILM Healthcare Americas Corporation Scenaria View 4.2 2023-10-12
K233583 FUJIFILM Healthcare Americas Corporation FCT iSTREAM Phase 1 2024-04-26
K151376 Covidien, LLC superDimension Navigation System 2015-11-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2011 GE Medical Systems, LLC 2
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017 Philips Medical Systems 2
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017 Philips Medical Systems 2
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017 Philips Medical Systems 2
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017 Philips Medical Systems 2
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Similar Registrations

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3010281549 J. MORITA MFG. CORP., TOTTORI FACTORY Kurayoshi Tottori, JP
2134213 CANON MEDICAL INFORMATICS, INC. MINNETONKA, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2134850. Last updated year: 2026. Please use registration number 2134850 when referencing this establishment in official correspondence.
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