Medical Device Manufacturer · US , Walker , MI

Infrasonics Corp. - FDA 510(k) Cleared Devices

20 submissions · 19 cleared · Since 1984

Recent clearances: ADULT VENTILATOR, OXY/STAR LOW FLOW BLENDER, STAR BREATHING CIRCUITS

20

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Infrasonics Corp. Anesthesiology ✕

18 devices

1-12 of 18

Cleared Dec 28, 1995

ADULT VENTILATOR

Anesthesiology · 547d

Cleared Sep 25, 1995

OXY/STAR LOW FLOW BLENDER

Anesthesiology · 94d

Cleared Oct 27, 1993

STAR BREATHING CIRCUITS

Anesthesiology · 23d

Cleared Dec 01, 1992

VENTILATOR ADULT STAR MODIFICATION

Anesthesiology · 181d

Cleared Oct 22, 1992

INFANT STAR SERIES 500

Anesthesiology · 90d

Cleared Aug 24, 1992

MODEL 105 VENTILATOR, MODIFICATION

Anesthesiology · 89d

Cleared Aug 03, 1992

Anesthesiology · 159d

Cleared Jun 11, 1992

INFRASONICS VENTILATOR ADULT STAR, MODIFICATION

Anesthesiology · 414d

Cleared Jan 09, 1992

STAR SYNC, MODIFICATION

Anesthesiology · 126d

Cleared Jan 30, 1991

ADULT STAR, MODIFICATION

Anesthesiology · 68d

Cleared Mar 16, 1990

MODIFIED STAR CALC

Anesthesiology · 156d

Cleared Jun 08, 1989

Anesthesiology · 224d