FDA Registration
Active
🇮🇱 Israel
Transducer
Reg #: 3006891665
·
FEI: 3006891665
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ELCAM MEDICAL ACAL
- Registration Number
- 3006891665
- FEI Number
- 3006891665
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- D.N. MEROM HAGALIL
- City
- DALTON INDUSTRIAL PARK, P.O BOX 9 Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K120624
Owner / Operator
- Firm Name
- Elcam Medical ACAL
- Operator Number
- 8030082
- Address
- Kibbutz BarAm
- City
- D.N Merom Hagalil
- State
- Northern
- Postal Code
- 1386000
- Country
- IL
- Correspondent
- Yaniv - Menachem
US Agent
- Business Name
- ELCAM MEDICAL INC.
- Contact Name
- Tomer Gil
- Address
- 1 University Plz, SUITE 511
- City
- Hackensack
- State
- NJ
- ZIP
- 07601
- Country
- US
- [email protected]
- Phone
- 201 4571120 ext. 112
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Blood-Pressure, Extravascular | DRS | Class 2 | Cardiovascular | No | 2013-01-17 |
Proprietary Names
Transducer
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)