FDA Registration
Active
🇺🇸 United States
Kimball Solutions Jasper, Inc.
Reg #: 3008253300
·
FEI: 3008253300
·
Expires 2026
Products
10
Proprietary Names
9
Establishment Types
2
Classifications
10
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Registration Details
- Registration Name
- Kimball Solutions Jasper, Inc.
- Registration Number
- 3008253300
- FEI Number
- 3008253300
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1038 E 15th Street
- City
- Jasper
- State
- IN
- ZIP
- 47546
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190626
Owner / Operator
- Firm Name
- KIMBALL SOLUTIONS GROUP, LLC
- Operator Number
- 9071700
- Address
- 1205 Kimball Blvd.
- City
- Jasper
- State
- IN
- Postal Code
- 47546
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2019-05-16 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2019-05-16 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2019-05-16 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2022-07-05 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2013-01-09 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2013-01-09 |
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | Class 2 | Neurology | No | 2013-01-09 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2013-09-23 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 2024-07-18 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2024-07-18 |
Proprietary Names
IntraSight Mobile
SyncVision System
EZ-1 System Respiratory Sensor
Alice NightOne
Alice PSG Components
OmniLab Connect
DreamStation Link Module, Nirvana
MRPC PORTAL 5000 DESKTOP - Philips MRPC
MRPC PORTAL 5000 DESKTOP - INVIVO
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device