FDA Registration
Active
🇺🇸 United States
DVI FOUR FIBER OUTPUT MODULE (90T1009)
Reg #: 2518897
·
FEI: 1000080301
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PENTAX of America, Inc.
- Registration Number
- 2518897
- FEI Number
- 1000080301
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3 Paragon Drive
- City
- MONTVALE
- State
- NJ
- ZIP
- 07645
- Country
- US
Owner / Operator
- Firm Name
- HOYA Corporation PENTAX Division
- Operator Number
- 8030235
- Address
- 3 Paragon Drive
- City
- Montvale
- State
- NJ
- Postal Code
- 07645
- Country
- US
- Correspondent
- Gurvinder Nanda
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2017-10-30 |
Proprietary Names
DVI FOUR FIBER OUTPUT MODULE (90T1009)
DVI OUTPUT MODULE (90T1006)
SCALEOR, DVI INPUT, W/OUT FIBER (SCALE OR)
3G/HD-SDI/SDI INPUT MODULE (90T1007)
DVI INPUT MODULE (90T1005)
SCALEOR, DVI INPUT, W/FIBER (90T0010)
3G/HD-SDI/SDI OUTPUT MODULE (90T1008)
FSN VIDEO SWITCHING PACKAGE (FSNIPS 1000A)
Establishment Types
Complaint File Establishment per 21 CFR 820.198