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510(k) K863778

Device
VENTICIS II
Applicant
CIS-US, INC.
510(k) number
K863778
Product code
IYT  
Decision
Substantially Equivalent (SESE)
Decision date
1986-10-27
Date received
1986-09-26
Regulation
892.1390
Classification name
System, Rebreathing, Radionuclide
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MALAMUD, PHD
Address
1983 Marcus Ave. Lake Success NY US 11042 11042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IYT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200916Patient Administration SetCyclomedica Australia Pty, Ltd.2020-09-01
K953513XENON CIRCUITKing Systems Corp.1995-11-03
K952223XENON GAS BREATHING CIRCUITIntertech Resources, Inc.1995-08-11
K914747XENON CIRCUITGibeck, Inc.1992-02-27
K913416TETLEY PATIENT ADMINISTRATION SETTetley Medical , Ltd.1991-10-28
K912626BOLUS XENON CIRCUITVital Signs, Inc.1991-08-02
K904684AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATIONAmici, Inc.1991-01-14
K903805AMICI XENON ADMINISTRATION SETAmici, Inc.1991-01-14
K903694AMICI TRU-FIT SOFT PLASTIC MOUTHPIECEAmici, Inc.1990-10-03
K896885DISPOSABLE RESPIRTORY KIT (MP-200)Medipart Jerry Alexander1990-02-26
K896125MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133MMedipart Jerry Alexander1990-02-01
K896124MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133Medipart Jerry Alexander1990-01-22
K896475DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELDMedipart Jerry Alexander1990-01-22
K896476DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELDMedipart Jerry Alexander1990-01-22
K881812AERO-MIST NEBULIZERCadema Medical Products, Inc.1988-07-18

Legacy Summary#

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FDA Review#

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