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510(k) K924341

Device
HAYEK OSCILLATOR(TM)
Applicant
RESPIRONICS, INC.
510(k) number
K924341
Product code
BYT  
Decision
Substantially Equivalent (SESE)
Decision date
1993-07-21
Date received
1992-08-27
Regulation
868.5935
Classification name
Ventilator, External Body, Negative Pressure, Adult (cuirass)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RICHARD G CONFER
Address
1001 Murry Ridge Ln. Murrysville PA US 15668 15668

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BYT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K082657RTX RESPIRATORMedivent Limited2008-10-08
K072290PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUSDima Italia Srl2008-05-29
K910947NEV-10 NEGATIVE PRESSURE VENTILATORLifecare Services, Inc.1991-06-03
K905530PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEMPuritan Bennett Corp.1991-03-01
K902764EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARMJ. H. Emerson Co.1990-11-19
K903745THE HAYEK OSCILLATORFlexco Medical Instruments1990-11-09
K902300EASY BREATHER MODEL 100 ACCESSORIESProgressive Productions , Ltd.1990-07-19
K895849RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEMRespironics, Inc.1989-12-22
K894649EMERSON 33-CR CHEST RESPIRATOREmerson Intl. Co.1989-10-13
K893213EASY BREATHER MODEL 100Progressive Productions , Ltd.1989-08-04
K881808EMERSON CHEST RESPIRATOR, MODEL 33-CREJ. H. Emerson Co.1988-08-04
K881689LINDLEY II RESUSCITATORLindley Resuscitator, Inc.1988-07-08
K863300Q101 DIAGNOSTIC SPIROMETERQuinton, Inc.1986-11-13
K860692PTR MK II VENTILATORBear Medical Systems, Inc.1986-05-21
K840885LAKEVILLE BODY VENTILATOREdwards Ventilator Co.1984-07-12

Legacy Summary#

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FDA Review#

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