FDA Registration
Active
🇺🇸 United States
BioStamp NPoint
Reg #: 3009503584
·
FEI: 3009503584
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- HCLTech
- Registration Number
- 3009503584
- FEI Number
- 3009503584
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 248 Armstrong Rd
- City
- Pittston
- State
- PA
- ZIP
- 18640
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173510
Owner / Operator
- Firm Name
- HCL America, Inc.
- Operator Number
- 10084715
- Address
- 248 Armstong Road
- City
- Pittston
- State
- PA
- Postal Code
- 18640
- Country
- US
- Correspondent
- Heather Ferrence
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2022-03-24 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-03-24 |
| Device, Sleep Assessment | LEL | Class 2 | Neurology | No | 2022-03-24 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2022-03-24 |
Proprietary Names
BioStamp NPoint
Establishment Types
Repack or Relabel Medical Device