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510(k) K941781

Device
RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM
Applicant
DACOMED CORP.
510(k) number
K941781
Product code
LIL  
Decision
Substantially Equivalent (SESE)
Decision date
1994-08-25
Date received
1994-04-11
Regulation
510(k) Premarket Notification
Classification name
Monitor, Penile Tumescence
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Gastroenterology/Urology
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARY M WILEN
Address
1701 E. 79th St., Suite 17 Minneapolis MN US 55425 55425

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LIL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K061676RIGIDOMETER, MODEL DIR-4UUroan 212006-12-27
K062042PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)Plethora Solutions2006-09-06
K052929PREFTEST PROFESSIONAL SUITELimestone Technologies, Inc.2006-04-26
K033126MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEMBehavioral Technology, Inc.2003-10-29
K000194DIGITAL INFLECTION RIGIDOMETER (DIR)Uroan Xxi Electromedicina2000-04-10
K991479VISER PENILE TUMESCENCE MONITORLaborie Medical Tech Corp.1999-07-07
K980627NEVA SYSTEMUrometrics, Inc.1998-04-07
K940128CAT-400UL PENILE PLETHYSMOGRAPHFarrall Instruments, Inc.1995-01-10
K936115CAT-600 PENILE PLETHYSMOGRAPHFarrall Instruments, Inc.1995-01-10
K925931RT2 RIGIDITY AND TUMESCENCE TESTCompass Medical Technologies, Inc.1992-12-21
K880903BARD (R) ESKA ERECTIOMETERC.R. Bard, Inc.1988-05-06
K875333SURGITEK NPT MONITORSurgitek1988-04-13
K870983NOCTURNAL PENILE TUMESCENCE MONITORTexas Medical Electronics Co.1987-06-23
K851646VIBRECTORMulticept, Aps.1985-08-21
K841879LFT - 212Medical Monitoring Systems, Inc.1984-07-26

Legacy Summary#

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FDA Review#

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