Spiracle Technology
Los Alamitos, CA, US
SPIRACLE TECHNOLOGY appears in FDA device records in Los Alamitos, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Spiracle Technology between 1996 and 1998. The busiest year on record is 1998, with 2. The most recent is 1998, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K982225 | SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 | BTL | Substantially Equivalent | |
| K973347 | TSX PRM PULMONARY RESUSCITATION MONITOR | CAP | Substantially Equivalent | |
| K963755 | SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR | CBP | Substantially Equivalent | |
| K953349 | SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE | CBP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2030745 | 3000204983 | SPIRACLE TECHNOLOGY | 10601 Calle Lee Ste 190, Los Alamitos, CA 90720 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DXQBlood Pressure Cuff
- BSYCatheters, Suction, Tracheobronchial
- BXYFlowmeter, Calibration, Gas
- CCWLaryngoscope, Rigid
- KGBMask, Oxygen, Non-Rebreathing
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- DQAOximeter
- CANRegulator, Pressure, Gas Cylinder
- CBPValve, Non-Rebreathing
- BTMVentilator, Emergency, Manual (Resuscitator)
- BTLVentilator, Emergency, Powered (Resuscitator)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain