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510(k) K112546

O_TWO CPAP SYSTEM by O-Two Medical Technologies, Inc. — Product Code BYE

K112546 is an FDA 510(k) premarket notification submitted by O-Two Medical Technologies, Inc. for the device "O_TWO CPAP SYSTEM". The FDA issued a decision of Substantially Equivalent on December 27, 2011. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. O-Two Medical Technologies, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2011
Date Received
September 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
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)
  • K093862 — CAREVENT HANDHELD CPAP SYSTEM (May 6, 2010)
  • 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 BYE

  • K160112 — Besmed PEEP Valve (April 29, 2016)
  • K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE (April 14, 2014)
  • K133210 — B&B BUBBLER (March 28, 2014)
  • K122610 — PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES (August 5, 2013)
  • K110713 — WATERPAP VALVE (September 12, 2011)
  • K103833 — NEOPIP PATIENT CIRCUIT WITH PEEP (April 20, 2011)
  • K092029 — VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 (August 6, 2010)
  • K090710 — MERCURY CPAP (August 20, 2009)
  • K090317 — BABI*PLUS BUBBLE PAP VALVE (May 20, 2009)
  • K081266 — MERCURY MEDICAL PEEP VALVE (March 5, 2009)

FDA data resources