FDA Registration
Active
🇺🇸 United States
SPIRACLE TECHNOLOGY
Reg #: 2030745
·
FEI: 3000204983
·
Expires 2026
Products
9
Proprietary Names
11
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- SPIRACLE TECHNOLOGY
- Registration Number
- 2030745
- FEI Number
- 3000204983
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10601 Calle Lee Ste 190
- City
- Los Alamitos
- State
- CA
- ZIP
- 90720
- Country
- US
Regulatory Submissions
- 510(k) Number
- K031434
Owner / Operator
- Firm Name
- SPIRACLE TECHNOLOGY
- Operator Number
- 9026347
- Address
- 10601 Calle Lee, Ste 190, --
- City
- Los Alamitos
- State
- CA
- Postal Code
- 90720
- Country
- US
- Correspondent
- MICHAEL - SARNE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2009-03-06 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2023-05-26 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2010-11-17 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 1996-06-06 |
| Flowmeter, Calibration, Gas | BXY | Class 1 | Anesthesiology | No | 1996-06-06 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2009-03-06 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2009-03-06 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2013-12-04 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2009-03-06 |
Proprietary Names
FERNO2
CPR MASK FERNO2
ORO2 REGULATOR
BravO2 Regulator
ORO2 FLOW CONTROL VALVE
302 OX Inhaltor
OX Inhalator
MVP
PEZO2
HFOC
Gaseous Oxygen Supply Valve
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device