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510(k) K861605

Device
SCHNEIDER-SHILEY PRESSURE MANOMETER
Applicant
SHILEY, INC.
510(k) number
K861605
Product code
KRK  
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-28
Date received
1986-04-29
Regulation
870.1140
Classification name
Manometer, Blood-pressure, Venous
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MORTON BARAK
Address
17600 Gillette Ave. P.O. Box 19503 Irvine CA US 92714 92714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KRK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950607UST-5268P-5 TRANSDUCERAloka Co., Ltd.1995-09-15
K904674CENTRAL VENOUS PRESSURE MANOMETERMedex, Inc.1990-12-27
K884386ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCKEthitek Pharmaceuticals Co.1989-01-05
K875322MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETERSchneider-Shilley (Usa)1988-03-28
K830910MANOMETER SET C.V.P. #S 298/299Exco, Inc.1983-04-05
K813498MEDIFIXBurron Medical Products, Inc.1982-01-07
K813195MEDIFIX GRADUATED SCALEBurron Medical Products, Inc.1981-12-29
K790668VENOUS PRESSURE MONITOR, MF 35 LFDeco Medical, Inc.1979-05-23

Legacy Summary#

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FDA Review#

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