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510(k) K912128

Device
MAXI-SCOPE OR ULTRA-SCOPE
Applicant
SEIICHI MFG., INC.
510(k) number
K912128
Product code
LDE  
Decision
Substantially Equivalent (SESE)
Decision date
1991-06-28
Date received
1991-05-14
Regulation
870.1875
Classification name
Stethoscope, Manual
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
SHIRLEY MASAOKA
Address
95 Riverside Dr. Jamestown KY US 42629 42629

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LDE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945082CYPRESS MEDICAL PRODUCTS STETHOSCOPECypress Medical Products, Ltd.1994-12-08
K944337VARIOUS STETHOSCOPESRud Riester GmbH & CO KG1994-11-30
K940578MANUAL STETOSCOPEBhs Intl., Inc.1994-04-26
K935944PROSCOPES AND ADSCOPESAmerican Diagnostic Corp.1994-03-03
K923327STETHOSCOPE COVERAnup Chakraborty Co.1992-11-03
K924095TIMEOSCOPE AND FLEXISCOPEStethoscopes of America, Inc.1992-10-20
K914100STETHOSCOPEAtlas Medical Products, Inc.1991-11-07
K905487VARIOUS TYPES OF STETHOSCOPESLiaoning-Usa Corp.1991-04-09
K904547STETHOSCOPEKimball Industries Co., Ltd.1991-03-21
K895545V*S*R(TM) SCOPEVsr Enterprises Corp.1989-11-15
K890126KAMED STETHOSCOPED.R.G.1989-04-21
K882324STETH-SHIELD ACCESSORY TO A STETHOSCOPESteth-Shield, Inc.1988-07-18
K871369VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:Keeler Instruments, Inc.1987-09-24
K860473DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPESchering Corp.1986-08-14
K854771SALTZMAN STETHOSCOPE HEADK & S Medicorp1986-05-09

Legacy Summary#

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FDA Review#

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