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Found 3 results
510(k) Data Aggregation
K Number
K001129Device Name
PROLONG, MODELS PL50, PL100, PL150Manufacturer
Date Cleared
2000-07-06
(90 days)
Product Code
Regulation Number
868.5140Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K954505Device Name
EZ STIMManufacturer
Date Cleared
1996-12-10
(439 days)
Product Code
Regulation Number
868.2775Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH INTL., 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
K955031Device Name
MAXISTIMManufacturer
Date Cleared
1996-12-10
(404 days)
Product Code
Regulation Number
868.2775Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
LIFE-TECH INTL., 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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