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510(k) K873170

Device
ARIES
Applicant
MOUNTAIN MEDICAL EQUIPMENT, INC.
510(k) number
K873170
Product code
BYE  
Decision
Substantially Equivalent (SESE)
Decision date
1987-09-25
Date received
1987-08-11
Regulation
868.5965
Classification name
Attachment, Breathing, Positive End Expiratory Pressure
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES W MORGAN
Address
10488 W. Centennial Rd. Littleton CO US 80127 80127

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BYE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K160112Besmed PEEP ValveBesmed Health Business Corp2016-04-29
K133957DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USEGalemed Corp.2014-04-14
K133210B&B BUBBLERS & T Medical Technologies, Inc.2014-03-28
K122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.2013-08-05
K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.2011-12-27
K110713WATERPAP VALVEAirways Development, LLC2011-09-12
K103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.2011-04-20
K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG2010-08-06
K090710MERCURY CPAPMercury Medical2009-08-20
K090317BABI*PLUS BUBBLE PAP VALVEA Plus Medical2009-05-20
K081266MERCURY MEDICAL PEEP VALVEMercury Enterprizes Dba Mercury Medical2009-03-05
K080256PULMODYNE CHF FLOW GENERATOR SYSTEMPulmodyne2008-05-09
K070416NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEPNeoforce Group, Inc.2007-05-29
K050918KOO AMERICAS VALVE PEEP, MODEL KM-809Koo Americas, Inc.2005-06-06
K013884BOUSSIGNAC C.P.A.P. DEVICEVygon SA2003-01-21

Legacy Summary#

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FDA Review#

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