FDA Registration
Active
🇮🇱 Israel
WatchPAT 300
Reg #: 3017638059
·
FEI: 3017638059
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Itamar Medical Ltd. (Alon)
- Registration Number
- 3017638059
- FEI Number
- 3017638059
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11 Alon HaTavor St, South Industrial Park
- City
- Caesarea Haifa
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K222331
Owner / Operator
- Firm Name
- ITAMAR MEDICAL INC
- Operator Number
- 9041901
- Address
- 3290 Cumberland Club Drive, Suite 100
- City
- Atlanta
- State
- GA
- Postal Code
- 30339
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2022-12-14 |
Proprietary Names
WatchPAT 300
WP300
WatchPAT-300
uPAT Probe
WatchPAT Central+ kit
Watch-PAT300
RESBP sensor
WatchPAT300
CentralPlus sensor
Establishment Types
Manufacture Medical Device