Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2023374

FEI Number

2023374

Entity Name

DIVERSATEK HEALTHCARE INC.

City/State/Country

Highlands Ranch, CO, US

Establishment Address

9150 Commerce Center Cir Ste 500, Highlands Ranch, CO 80129, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

DIVERSATEK HEALTHCARE (Owner Number: 2023374)

Owner / Operator Contact Address

9150 COMMERCE CENTER CIR.,#500, --, Highlands Ranch, CO 80129, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K971214

PMA Number

N/A

All Registered Proprietary Names

MUI Pump HRIM InSight Ultima Insight G3 Insight G2 Sensor PAC Greenfield ZVU PriZm ZepHr Viscous Swallow Challenge Cadwell

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2012-06-04
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2012-06-05
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2020-10-12
FFT	Electrode, Ph, Stomach	Gastroenterology, Urology	Class 1	876.1400	2012-06-05
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2007-12-11
QIS	Esophageal, Mucosal, Electrical Characterization	Gastroenterology, Urology	Class 2	876.1450	2023-05-03
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2017-01-19
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2017-01-19
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2017-01-19
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2017-01-19
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2017-01-19
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2017-01-19
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2017-01-19
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2017-01-19

Official Correspondent

Laura Boll

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DIVERSATEK HEALTHCARE

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
K883960	Vascular Technology Incorporated	GIPHY MONITOR	1989-10-04
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24
K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.

Similar Registrations

Registration Number	Establishment Name	Location
9611668	MUI SCIENTIFIC	MISSISSAUGA Ontario, CA
3015198783	ANKON MEDICAL TECHNOLOGIES (SHANGHAI) CO., LTD.	Shanghai, CN
3010381606	EMSERE BV	Leiden Zuid-Holland, NL
3012302888	QUIPMENT INC.	Kennesaw, GA, US
3011790297	DEMCON PRODUCTION B.V.	Enschede Overijssel, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2023374. Last updated year: 2026. Please use registration number 2023374 when referencing this establishment in official correspondence.