FDA Registration
Active
🇺🇸 United States
DIVERSATEK HEALTHCARE INC.
Reg #: 2023374
·
FEI: 2023374
·
Expires 2026
Products
12
Proprietary Names
15
Establishment Types
5
Classifications
12
Registration Details
- Registration Name
- DIVERSATEK HEALTHCARE INC.
- Registration Number
- 2023374
- FEI Number
- 2023374
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 9150 Commerce Center Cir Ste 500
- City
- Highlands Ranch
- State
- CO
- ZIP
- 80129
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062222
Owner / Operator
- Firm Name
- DIVERSATEK HEALTHCARE
- Operator Number
- 2023374
- Address
- 9150 COMMERCE CENTER CIR.,#500, --
- City
- Highlands Ranch
- State
- CO
- Postal Code
- 80129
- Country
- US
- Correspondent
- Laura L Boll
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Gastrointestinal Motility (Electrical) | FFX | Class 2 | Gastroenterology, Urology | No | 2012-06-04 |
| Electrode, Ph, Stomach | FFT | Class 1 | Gastroenterology, Urology | No | 2012-06-05 |
| Esophageal, Mucosal, Electrical Characterization | QIS | Class 2 | Gastroenterology, Urology | No | 2023-05-03 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2017-01-19 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2017-01-19 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2017-01-19 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2017-01-19 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2017-01-19 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2017-01-19 |
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2017-01-19 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2017-01-19 |
| Monitor, Esophageal Motility, Anorectal Motility, And Tube | KLA | Class 2 | Gastroenterology, Urology | No | 2012-06-04 |
Proprietary Names
MUI Pump
HRIM
InSight Ultima
Insight G3
Insight G2
Sensor PAC
Greenfield
ZVU
PriZm
ZepHr
Viscous Swallow Challenge
Cadwell
Clinical Innovations probes
ComforTEC Plus
Buffer
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)