FDA Registration
Active
🇰🇷 South Korea
LifeSignals Multi-parameter Remote Monitoring Platform
Reg #: 3014848734
·
FEI: 3014848734
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- DREAMTECH CO., LTD.
- Registration Number
- 3014848734
- FEI Number
- 3014848734
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 161, Asanbaelli-Ro 388 Beon-Gil, Eumbong-Myeon
- City
- Asan-si Chungnam
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K202868
Owner / Operator
- Firm Name
- Dreamtech co., ltd.
- Operator Number
- 10058403
- Address
- 670 Daewangpangyo-ro, Bundang-gu
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13494
- Country
- KR
- Correspondent
- Donghwan Kim
US Agent
- Business Name
- LifeSignals, Inc.
- Contact Name
- Saravanan Balasubramanian
- Address
- 426 South Hillview Drive
- City
- Milpitas
- State
- CA
- ZIP
- 95035
- Country
- US
- [email protected]
- Phone
- 510 7706412 ext. 4
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2021-07-23 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2021-07-23 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-07-23 |
Proprietary Names
LifeSignals Multi-parameter Remote Monitoring Platform
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)