FDA Registration
Active
🇺🇸 United States
Cocoon Portable Handheld X-Ray System
Reg #: 3011471624
·
FEI: 3011471624
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- RAY AMERICA INC
- Registration Number
- 3011471624
- FEI Number
- 3011471624
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 400 Kelby Street, Ste. 1500
- City
- Fort Lee
- State
- NJ
- ZIP
- 07024
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173046
Owner / Operator
- Firm Name
- RAY AMERICA INC
- Operator Number
- 10048938
- Address
- 400 Kelby Street, Ste. 1500
- City
- Fort Lee
- State
- NJ
- Postal Code
- 07024
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2024-07-15 |
Proprietary Names
Cocoon Portable Handheld X-Ray System
Establishment Types
Complaint File Establishment per 21 CFR 820.198