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510(k) K952616

Device
MICROTIME
Applicant
WESTMED INTL.
510(k) number
K952616
Product code
BTI  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-27
Date received
1995-06-06
Regulation
868.6250
Classification name
Compressor, Air, Portable
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LYNN HAYSE
Address
3351 E. Hemisphere Loop Tucson AZ US 85706 85706

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BTI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K131881OMBRA TABLE TOP COMPRESSORTrudell Medical Intl.2013-10-24
K113338MEDICAL AIR COMPRESSOROricare, Inc.2012-08-10
K091871DK50 DSEkom S.R.O.2009-10-23
K072634EMG TRITON -COMP,MODEL NCA01-XXX SERIESEmg Technology Co., Ltd.2008-11-19
K060781MEDICAL COMPRESSOR, MODELS DK50 D AND DMEkom S.R.O.2006-10-03
K051691MINIMATE COMPRESSORPrecision Medical, Inc.2005-12-09
K041781VENTILAIR II MEDICAL AIR COMPRESSORHamilton Medical AG2005-03-14
K041406NEWPORT C250 AIR COMPRESSOR MODEL C250Newport Medical Instruments2004-12-15
K041974MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZERMed2000 S.R.L.2004-08-24
K040220MEDICAL AIR COMPRESSOReVent Medical, Ltd.2004-06-09
K031686AEROMIST LT, MODEL HCS15004Medline Industries, Inc.2004-01-21
K031413VIGORMIST COMPRESSOR NEBULIZERVega Technologies, Inc.2003-10-07
K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81ESiemens Elema AB2003-09-05
K020797PULMO-MIST COMPRESSOR MODEL # 4323Nidek Medical Products, Inc.2002-05-03
K013027MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123Respironics Healthscan, Inc.2001-12-06

Legacy Summary#

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FDA Review#

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