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510(k) K961867

PEEP VALVE by Medical Marketing Concepts — Product Code BYE

K961867 is an FDA 510(k) premarket notification submitted by Medical Marketing Concepts for the device "PEEP VALVE". The FDA issued a decision of Substantially Equivalent on August 13, 1996. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Medical Marketing Concepts has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1996
Date Received
May 15, 1996
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 Medical Marketing Concepts

  • K982215 — MANUAL RESUSCITATOR WITH ACE (September 18, 1998)
  • K961330 — BAGRIGHT INFANT RESUSCITATOR (July 2, 1996)
  • K961329 — BAGRIGHT CHILD RESUSCITATOR (July 2, 1996)
  • K961868 — RESPOSABLE CHILD RESUSCITATOR (June 28, 1996)
  • K961369 — BAGRIGHT RESPOSABLE RESUSCITATOR (June 28, 1996)
  • K961331 — BAGRIGHT RESPOSABLE CHILD RESUSCITATOR (June 28, 1996)
  • K961332 — BAGRIGHT RESPOSABLE INFANT RESUSCITATOR (June 28, 1996)
  • K961882 — RESPOSABLE INFANT RESUSCITATOR (June 28, 1996)
  • K953546 — MANUAL PULMONARY RESUSICITATOR (February 29, 1996)
  • K954296 — BAGRIGHT RESUSCITATOR (December 20, 1995)

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)
  • 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)

FDA data resources