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510(k) K920063

Device
DISETRONIC DOLOMAT PUMP
Applicant
DISETRONIC MEDICAL SYSTEMS
510(k) number
K920063
Product code
FRW  
Decision
Substantially Equivalent (SESE)
Decision date
1993-08-03
Date received
1992-01-07
Regulation
880.2720
Classification name
Scale, Patient
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JIM MYERS
Address
13911 Ridgedale Dr. Suite 254 Minnetonka MN US 55343 55343

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FRW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K955357OLYMPIC SMART SCALE MODEL 50/50RAOlympic Medical Corp.1996-01-30
K955177OLYMPIC SMART SCALEOlympic Medical Corp.1995-12-14
K954846OLYMPIC SMART SCALEOlympic Medical Corp.1995-12-14
K952649WARM-SCALEOlympic Medical Corp.1995-08-15
K943587ADVANCED IN-BED WEIGH SYSTEMFuture Systems, Inc.1994-09-22
K932572DIGITAL BABY SCALE MODEL BLB-12Tanita Corp. of America1993-11-16
K926174MODEL 9100 H.R. INFANT SCALEAcme Medical Scale Co.1993-10-25
K926446EZ PUMPAlphamed, Inc.1993-09-27
K9260583M MODEL 280RT RATE TAPER INFUSION PUMP3M Health Care, Ltd.1993-08-16
K9260593M MODEL 200RT RATE TAPER INFUSION PUMP3M Health Care, Ltd.1993-08-16
K930626SANITAS PATIENT SCALEDutton-Lainson Co.1993-08-06
K924847DETECTO MODEL 6700 SERIESCardinal Scale Mfg. Co.1993-05-24
K922119MODEL 5002 LIFT WEIGH-SCALEAcme Medical Scale Co.1993-02-03
K920812FAIRBANKS BABY SCALEFairbanks Scales, Inc.1992-05-13
K920074ARJO CENTURY SCALES WITH REMOTEArjo-Century, Inc.1992-04-06

Legacy Summary#

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FDA Review#

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