FDA Registration
Active
🇺🇸 United States
NIMBLEHEART, INC.
Reg #: 3021219789
·
FEI: 3021219789
·
Expires 2026
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- NIMBLEHEART, INC.
- Registration Number
- 3021219789
- FEI Number
- 3021219789
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1180 Miraloma Way, Suite K
- City
- Sunnyvale
- State
- CA
- ZIP
- 94085
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171244
Owner / Operator
- Firm Name
- NimbleHeart, Inc.
- Operator Number
- 10084058
- Address
- 1180 Miraloma Way, Suite K
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94085
- Country
- US
- Correspondent
- Sonal Tambe
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-01-12 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2022-01-12 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2022-01-12 |
Proprietary Names
Physiotrace Smart
Establishment Types
Manufacture Medical Device