JVC
- Primary DI
- 00046838078880
- Company
- JVC KENWOOD CORPORATION
- Model
- CL-S200
- Published
- 2018-10-25
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Regulatory Flags
- DUNS number
- 713321040
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00046838078880 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 00046838078880 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| PGY | Display, Diagnostic Radiology | 2 | Radiology | 892.2050 | N | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K173434 | 000 | 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 | Jvckenwood Corporation | 2017-12-14 | PGY |
GMDN Terms
| Term | Definition |
|---|
| Image display unit, colour | An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This group of devices is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD). |
Device Sizes
No records found.
Storage And Handling
No records found.
Contacts
No records found.
Other Devices From This Company
Other Devices Sharing Product Codes