Medical Device Manufacturer · US , Irvine , CA

Spiracle Technology - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1996

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spiracle Technology Anesthesiology ✕

4 devices

1-4 of 4

Cleared Oct 28, 1998

SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504

Anesthesiology · 126d

Cleared Jul 23, 1998

TSX PRM PULMONARY RESUSCITATION MONITOR

Anesthesiology · 321d

Cleared Apr 08, 1997

SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR

Anesthesiology · 202d

Cleared Feb 29, 1996

SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE

Anesthesiology · 227d