FDA Registration
Active
🇺🇸 United States
Jumper Pulse Oximeter
Reg #: 3011721071
·
FEI: 3011721071
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ALC ENTERPRISES INC
- Registration Number
- 3011721071
- FEI Number
- 3011721071
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 134 Stockton Street, 1C
- City
- Brooklyn
- State
- NY
- ZIP
- 11206
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140582
Owner / Operator
- Firm Name
- Aura Medical LLC
- Operator Number
- 10049729
- Address
- 2 Skillman Street, Suite 512
- City
- Brooklyn
- State
- NY
- Postal Code
- 11205
- Country
- US
- Correspondent
- Connie Lefkowitz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-05-13 |
Proprietary Names
Jumper Pulse Oximeter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility