FDA Registration
Active
🇺🇸 United States
DR200
Reg #: 1224919
·
FEI: 1000513706
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NORTHEAST MONITORING, INC.
- Registration Number
- 1224919
- FEI Number
- 1000513706
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 141 Parker Street, Suite # 200
- City
- MAYNARD
- State
- MA
- ZIP
- 01754
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061293
Owner / Operator
- Firm Name
- NORTHEAST MONITORING, INC.
- Operator Number
- 9021067
- Address
- 141 Parker Street, Suite #200
- City
- Maynard
- State
- MA
- Postal Code
- 01754
- Country
- US
- Correspondent
- SHERRY L STEELE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2007-11-13 |
Proprietary Names
DR200
DR200/Ea
DR200/HE
Telaheart
DR200/HEa
DR200 Series
LX Event
Establishment Types
Manufacture Medical Device