Medical Device Manufacturer · CA , Mississauga

O-Two Medical Technologies, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2005

Recent clearances: Equinox Advantage, O-TWO E700,O-TWO E600,O-TWO E500, EQUINOX RELIEVE

View 8 510(k) Devices ↓

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - O-Two Medical Technologies, Inc. Anesthesiology ✕

8 devices

1-8 of 8

Cleared Aug 29, 2018

Equinox Advantage

Anesthesiology · 331d

Cleared Mar 16, 2015

O-TWO E700,O-TWO E600,O-TWO E500

Anesthesiology · 276d

Cleared Apr 30, 2012

EQUINOX RELIEVE

Anesthesiology · 137d

Cleared Dec 27, 2011

O_TWO CPAP SYSTEM

Anesthesiology · 117d

Cleared May 06, 2010

CAREVENT HANDHELD CPAP SYSTEM

Anesthesiology · 140d

Cleared Mar 06, 2009

CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)

Anesthesiology · 298d

Cleared Sep 28, 2005

CAREVENT ATV+ AND CAREVENT MRI

Anesthesiology · 117d

Cleared Aug 30, 2005

CAREVENT CA AND DRA

Anesthesiology · 49d