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510(k) K060265

Device
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
Applicant
Remcore, Inc.
510(k) number
K060265
Product code
CAN
Decision
Substantially Equivalent (SESE)
Decision date
2006-10-25
Date received
2006-02-01
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
N

Applicant Contact#

Contact
KEVIN JORCZAK
Address
14 Bond St. Boston MA US 02118 02118

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
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
K914271GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)C.G.H. Medical, Inc.1992-04-13
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