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Found 3 results
510(k) Data Aggregation
K Number
K003127Device Name
REGAIN DESKTOPManufacturer
Date Cleared
2001-01-04
(90 days)
Product Code
Regulation Number
882.5050Type
TraditionalPanel
NeurologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
SRS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K003367Device Name
ORION PLATINUMManufacturer
Date Cleared
2001-01-04
(66 days)
Product Code
Regulation Number
882.5050Type
TraditionalPanel
NeurologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
SRS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K002834Device Name
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSORManufacturer
Date Cleared
2000-11-29
(78 days)
Product Code
Regulation Number
884.1425Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
SRS MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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