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510(k) K832678

Device
PHONATORY FUNCTION ANALYZER PS-77
Applicant
KELLS MEDICAL, INC.
510(k) number
K832678
Product code
BXP  
Decision
Substantially Equivalent (SESE)
Decision date
1984-03-07
Date received
1983-08-09
Regulation
868.2885
Classification name
Transducer, Gas Flow
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BXP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K936141UNIPOWER RECHARGEABLE BATTERY PACKUnipower Corp.1994-03-31
K920360TIMOX OXYGEN TIMERMedical Fittings, Inc.1992-08-03
K800087ULTRASONIC FLOWMETERThe Perkin-Elmer Corp.1980-03-19
K781039OXY-ON DIGITAL OXYGEN TIMERChambers & Sadler Mfg.1978-08-31
K770424OXYGEN TWMER, MODEL SSTTimeter Instrument Corp.1977-03-16
K761260ARIZONA OXYGEN TIMER DEVICEThe John Bunn Co.1976-12-16

Legacy Summary#

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FDA Review#

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