FDA Registration
Active
🇺🇸 United States
Ventilator, emergency, manual (resuscitator)
Reg #: 2020813
·
FEI: 2020813
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ACCUTRON, INC.
- Registration Number
- 2020813
- FEI Number
- 2020813
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1733 WEST PARKSIDE LN.
- City
- PHOENIX
- State
- AZ
- ZIP
- 85027
- Country
- US
Regulatory Submissions
- 510(k) Number
- K910040
Owner / Operator
- Firm Name
- Accutron Inc
- Operator Number
- 2020813
- Address
- 1733 W Parkside Lane
- City
- Phoenix
- State
- AZ
- Postal Code
- 85027
- Country
- US
- Correspondent
- Stephanie Wasielewski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2007-11-28 |
Proprietary Names
Ventilator, emergency, manual (resuscitator)
Establishment Types
Repack or Relabel Medical Device