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510(k) K895104

Device
AQUATREX UNDERWATER TREADMILL SYSTEM
Applicant
EDMONDS MEDICAL SYSTEMS
510(k) number
K895104
Product code
IOL  
Decision
Substantially Equivalent (SESE)
Decision date
1989-12-04
Date received
1989-08-15
Regulation
890.5380
Classification name
Treadmill, Powered
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROGER KELLER
Address
7711 230th SW Edmonds WA US 98020 98020

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IOL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950377PARKER MODEL PEParker Treadmill Co., Inc.1995-09-06
K950376PARKER MODEL PMParker Treadmill Co., Inc.1995-09-06
K925839TRACKMASTERJas Manufacturing Co., Inc.1993-06-24
K930261RTM REHABILITATION TREADMILL, MODEL #945-200Biodan Medical Systems, Ltd.1993-05-26
K904556MANSFIELD CARDIAC ASSIST MODEL 940(TM) IABBoston Scientific Corp1991-12-18
K913518TA620 TREADMILL CONTROLLERSiemens Burdick, Inc.1991-10-24
K910867T600 TREADMILLSiemens Burdick, Inc.1991-05-31
K911751MEDTRACK TREADMILLQuinton, Inc.1991-05-29
K897179ORBITER(TM) TREADMILLLee-Meredith Industries, Inc.1990-02-15
K893032PACER R 9 TREADMILLPacer Industries, Inc.1989-07-27
K890793STARTRACUnisen, Inc.1989-03-16
K885062MODIFIED Q-SERIES OF TREADMILLSQuinton, Inc.1988-12-27
K864013MODEL Q55XT POWERED TREADMILLQuinton, Inc.1986-11-14
K863299MODIFIED Q50 MEDICAL TREADMILLQuinton, Inc.1986-09-09
K862741Q50 MEDICAL TREADMILLQuinton, Inc.1986-07-29

Legacy Summary#

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FDA Review#

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