FDA Registration
Active
🇺🇸 United States
Electrode
Reg #: 2434982
·
FEI: 2434982
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GEMSTAR, INC.
- Registration Number
- 2434982
- FEI Number
- 2434982
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 27 ROBERT PITT DR.
- City
- MONSEY
- State
- NY
- ZIP
- 10952
- Country
- US
Regulatory Submissions
- 510(k) Number
- K896155
Owner / Operator
- Firm Name
- GEMSTAR, INC.
- Operator Number
- 2434982
- Address
- 27 ROBERT PITT DR., --
- City
- Monsey
- State
- NY
- Postal Code
- 10952
- Country
- US
- Correspondent
- EPHRAIM - GROSSMAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2017-09-14 |
Proprietary Names
Electrode
Establishment Types
Repack or Relabel Medical Device