Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004753785

FEI Number

3004753785

Entity Name

INOMED MEDIZINTECHNIK GMBH

City/State/Country

EMMENDINGEN Baden-Wurttemberg, DE

Establishment Address

IM HAUSGRUEN 29, EMMENDINGEN Baden-Wurttemberg D-79312, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INOMED MEDIZINTECHNIK GMBH (Owner Number: 9065889)

Owner / Operator Contact Address

IM HAUSGRUEN 29, --, EMMENDINGEN, DE-NOTA D-79312, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091874

PMA Number

N/A

All Registered Proprietary Names

Mapping Suction Probe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2012-02-21
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2012-02-21
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2022-01-10
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2022-01-10
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2022-01-10
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2022-01-10
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2022-01-10
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2022-01-10
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2022-12-16
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2013-10-30
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2011-06-10
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2023-11-07
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2023-11-07
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-11-07
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2023-11-07
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2023-11-07
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2023-02-10
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2023-02-10
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-01-12
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2016-11-09
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2009-12-03

Official Correspondent

No official correspondent registered.

US Agent Details

Adam Smith Business: inomed Inc Email: info@us.inomed.com Phone: (904) 7960398

Related Public Records

Same Entity

INOMED MEDIZINTECHNIK GMBH

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
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10
K150005	Ndi Medical, LLC	Checkpoint, Checkpoint Head & Neck	2015-02-19
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004753785. Last updated year: 2026. Please use registration number 3004753785 when referencing this establishment in official correspondence.