Home / 510(k) Clearances / K103833

510(k) K103833

NEOPIP PATIENT CIRCUIT WITH PEEP by Neoforce Group, Inc. — Product Code BYE

K103833 is an FDA 510(k) premarket notification submitted by Neoforce Group, Inc. for the device "NEOPIP PATIENT CIRCUIT WITH PEEP". The FDA issued a decision of Substantially Equivalent on April 20, 2011. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Neoforce Group, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2011
Date Received
December 30, 2010
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 Neoforce Group, Inc.

  • K110119 — PRESSURE MANOMETER (June 10, 2011)
  • K102649 — NEOPOP INFANT RESUSCITATOR WITH FLOW METER (January 6, 2011)
  • K092085 — ISPIRA RESUSCITATION UNIT (October 7, 2009)
  • K072021 — NEOPIP INFANT RESUSCITATOR (September 12, 2007)
  • K070416 — NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP (May 29, 2007)
  • K061280 — V-2200 INFANT INCUBATOR (June 27, 2006)

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)
  • K112546 — O_TWO CPAP SYSTEM (December 27, 2011)
  • K110713 — WATERPAP VALVE (September 12, 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