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510(k) K904144

Device
PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM
Applicant
MALLINCKRODT GROUP, INC.
510(k) number
K904144
Product code
IZP  
Decision
Substantially Equivalent (SESE)
Decision date
1990-12-13
Date received
1990-09-07
Regulation
892.1870
Classification name
Programmer, Changer, Film/cassette, Radiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
THOMAS F DONOHUE
Address
2111 E. Galbraith Rd. P.O. Box 156305 Cincinnati OH US 45215 45215

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IZP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934944MPQ-42Elema-Schonander, Inc.1993-12-15
K911888PHILIPS ANGIOPROPhilips Medical Systems North America, Inc.1991-10-15
K904103SEP 90Elema-Schonander, Inc.1990-11-20
K874451OMNIPLANE 200 FILM CHANGER SYSTEMMedrad, Inc.1988-02-11
K854251THE CSE FILM CHANGER SYSTEMChanger Service & Engineering, Inc.1985-10-28
K842903SEP PROGRAMMER FOR PUCK U & UD FILMCHANGElema-Schonander, Inc.1984-08-21
K841649MAXIMAX - 4Cgr Medical Corp.1984-06-05
K841732LIEBEL-FLARSHEIM AFC 1000 X-RAY FILMSybron Corp.1984-06-05
K840389SEP PROGRAMMER SEP-M/SINGLE-PLANE &Elema-Schonander, Inc.1984-02-21

Legacy Summary#

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FDA Review#

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