Medical Device Manufacturer · US , Colton , CA

Pulmonetic Systems, Inc. - FDA 510(k) Cleared Devices

12 submissions · 11 cleared · Since 1998

12

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pulmonetic Systems, Inc. Anesthesiology ✕

12 devices

1-12 of 12

Cleared Mar 18, 2009

PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR

Anesthesiology · 96d

Cleared Aug 01, 2007

PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

Anesthesiology · 152d

Cleared May 25, 2006

LTV 1200 VENTILATOR

Anesthesiology · 73d

Cleared May 04, 2006

AUTOMOBILE LIGHTER POWER CORD

Anesthesiology · 63d

Cleared Jul 29, 2005

LTV 1000 VENTILATOR

Anesthesiology · 29d

Cleared Jun 03, 2004

MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS

Anesthesiology · 66d

Cleared Apr 29, 2004

MODIFICATION TO LTV 1000 VENTILATOR

Anesthesiology · 58d

Cleared Oct 16, 2003

LTV-1000 VENTILATOR

Anesthesiology · 87d

Cleared Mar 20, 2001

MODIFICATION TO LAP TOP VENTILATOR (LTV)

Anesthesiology · 19d

Cleared Oct 11, 2000

VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000

Anesthesiology · 26d

Cleared Apr 12, 1999

Anesthesiology · 150d

Cleared Oct 30, 1998

LTV 1000 VENTILATOR

Anesthesiology · 197d