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510(k) K914271

Device
GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)
Applicant
C.G.H. MEDICAL, INC.
510(k) number
K914271
Product code
CAN  
Decision
Substantially Equivalent (SESE)
Decision date
1992-04-13
Date received
1991-09-24
Regulation
868.2700
Classification name
Regulator, Pressure, Gas Cylinder
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY R SHIDEMAN
Address
1185 Oak St. Lakewood CO US 80215 80215

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CAN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162811MR Conditional CGA 870Essex Industries, Inc.2017-03-02
K080243PORTABLE OXYGEN UNIT SCA900San Cheong Co. , Ltd.2009-04-07
K060265REMCORE REMOTE CONTROLLED OXYGEN REGULATORRemcore, Inc.2006-10-25
K061785CYL-FIL OXYGEN SYSTEMResponsive Respiratory, Inc.2006-09-07
K950777OXYGEN REGULATORMada Medical Products, Inc.1995-04-14
K942751VANGUARD SERIES GAS REGULATORSBuckman Co., Inc.1995-02-09
K936187LSPI PRESSURE REGULATORLife Support Products, Inc.1994-01-27
K9320061500 SERIES REGULATORPrecision Medical, Inc.1993-10-25
K921125AMBU OXYGEN REGULATORAmg, LLC1992-09-17
K915154GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELSC.G.H. Medical, Inc.1992-05-27
K915505REGULATOR FLOWMETERLifeguard Medical Products, Inc.1992-04-22
K912174SALTER LABS DISPOSABLE NIPPLE AND NUTSalter Labs1991-07-24
K901831PRECISION MEDICAL OXYGEN REGULATORPrecision Medical, Inc.1990-08-14
K901623AMBU OXYGEN REGULATORFlotec, Inc.1990-04-26
K895956RX02 EMERGENCY MEDICAL OXYGENProgressive Medical Applications Corp.1990-04-05

Legacy Summary#

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FDA Review#

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