Search Results
Found 4 results
510(k) Data Aggregation
K Number
K212830Device Name
CT3000Pro
Manufacturer
SRS Medical
Date Cleared
2021-12-21
(105 days)
Product Code
FEN, EXQ
Regulation Number
876.1620Why did this record match?
Applicant Name (Manufacturer) :
SRS Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CT3000Pro is intended for urodynamic testing. The equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The non-invasive option utilizes a penile cuff (UroCuff-Classic or UroCuff-DC) for non-invasive testing of bladder activity, by assessing the pressure necessary to interrupt urine flow.
The CT3000Pro is intended for use under the direction of a licensed physician or health care professional in an office or hospital setting.
Device Description
The CT3000Pro system is an urodynamics testing system which combines an all-in-one touchscreen PC with the CT3000Pro console. Patient information and all data from the tests are stored on the PC's hard disk and the printer enables the user to print a hard copy report of the recorded data. It features a scale to record urine flow, as well as a pump for cystometrogram and urethral pressure profile studies.
The CT3000Pro PC software runs three types of tests: (a) catheterized urodynamics, (b) non- invasive urodynamics, and (c) uroflow studies.
Ask a Question
K Number
K003127Device Name
REGAIN DESKTOP
Manufacturer
SRS MEDICAL SYSTEMS, INC.
Date Cleared
2001-01-04
(90 days)
Product Code
HCC
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
SRS MEDICAL SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K003367Device Name
ORION PLATINUM
Manufacturer
SRS MEDICAL SYSTEMS, INC.
Date Cleared
2001-01-04
(66 days)
Product Code
HCC
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
SRS MEDICAL SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K002834Device Name
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR
Manufacturer
SRS MEDICAL SYSTEMS, INC.
Date Cleared
2000-11-29
(78 days)
Product Code
HIR
Regulation Number
884.1425Why did this record match?
Applicant Name (Manufacturer) :
SRS MEDICAL SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1