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510(k) K122610

PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES by Sen MU Technology Co., Ltd. — Product Code BYE

K122610 is an FDA 510(k) premarket notification submitted by Sen MU Technology Co., Ltd. for the device "PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES". The FDA issued a decision of Substantially Equivalent on August 5, 2013. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2013
Date Received
August 27, 2012
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 for product code BYE

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  • K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE (April 14, 2014)
  • K133210 — B&B BUBBLER (March 28, 2014)
  • K112546 — O_TWO CPAP SYSTEM (December 27, 2011)
  • 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