FDA Registration
Active
🇺🇸 United States
Simplesense
Reg #: 3019891870
·
FEI: 3019891870
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Nanowear, Inc.
- Registration Number
- 3019891870
- FEI Number
- 3019891870
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 341 Science Park Rd, Suite 208
- City
- State College
- State
- PA
- ZIP
- 16803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201669
Owner / Operator
- Firm Name
- Nanowear, Inc.
- Operator Number
- 10082457
- Address
- 53 Boerum Place, Suite 3F
- City
- Brooklyn
- State
- NY
- Postal Code
- 11201
- Country
- US
- Correspondent
- Sunny Atkinson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2021-07-29 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2021-07-29 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2021-07-29 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2021-07-29 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2021-07-29 |
Proprietary Names
Simplesense
Establishment Types
Manufacture Medical Device