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510(k) K130951

Device
SIM
Applicant
SIMAVITA PTY LIMITED
510(k) number
K130951
Product code
KPN  
Decision
Substantially Equivalent (SESE)
Decision date
2013-08-22
Date received
2013-04-05
Regulation
876.2040
Classification name
Alarm, Conditioned Response Enuresis
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN J SMITH, MD,JD
Address
555 13th St., NW Washington DC US 20004 20004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KPN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971442HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5Humed, Inc.1998-01-08
K971855POTTY PAL AND FOREVER-DRYDigital Applications, Inc.1997-08-18
K962770UROSURGE ACUTRAINERPrinceton Regulatory Assoc.1996-08-01
K962416DRYTIME FOR BLADDER CONTROL SILENTBio-Systems Research1996-07-22
K955338DRYTIME FOR POTTY TRAININGHealth Sense Intl., Inc.1996-03-12
K943559REMOTE A'LERTHealth Sense Intl., Inc.1995-05-24
K943558PRO'TECTHealth Sense Intl., Inc.1995-05-24
K942057FISHER-PRICE DRY NIGHT MONITORFisher Price1994-07-28
K935915WET SENSEEdson Corp.1994-05-13
K934369DRI SLEEPERLaborie Medical Technologies, Ltd.1993-11-24
K930005DRITRAINERLaborie Medical Technologies, Ltd.1993-03-03
K921431POTTY PAGERIdeas For Living1992-07-21
K911279DRY TIMEHealth Sense Intl., Inc.1991-09-04
K903856WET-NO-MORE MONITORTravis Industries, Inc.1990-09-12
K901907PROFESSIONAL MONITORTravis Industries, Inc.1990-09-12

Legacy Summary#

summary

FDA Review#

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