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510(k) K093862

CAREVENT HANDHELD CPAP SYSTEM by O-Two Medical Technologies, Inc. — Product Code BTL

K093862 is an FDA 510(k) premarket notification submitted by O-Two Medical Technologies, Inc. for the device "CAREVENT HANDHELD CPAP SYSTEM". The FDA issued a decision of Substantially Equivalent on May 6, 2010. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. O-Two Medical Technologies, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2010
Date Received
December 17, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

Other clearances by O-Two Medical Technologies, Inc.

  • K173205 — Equinox Advantage (August 29, 2018)
  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • K113687 — EQUINOX RELIEVE (April 30, 2012)
  • K112546 — O_TWO CPAP SYSTEM (December 27, 2011)
  • K081330 — CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) (March 6, 2009)
  • K051469 — CAREVENT ATV+ AND CAREVENT MRI (September 28, 2005)
  • K051889 — CAREVENT CA AND DRA (August 30, 2005)

Other clearances for product code BTL

  • K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (April 4, 2025)
  • K221634 — Oxymag - Transport and Emergency Ventilator (May 24, 2023)
  • K202219 — VORTRAN GO2VENT with PEEP Valve (February 11, 2021)
  • K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (November 20, 2020)
  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K161420 — MOVES SLC (June 6, 2017)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)

FDA data resources