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Found 3 results
510(k) Data Aggregation
K Number
K010735Device Name
SPEEDYBELLManufacturer
Date Cleared
2001-08-17
(158 days)
Product Code
Regulation Number
876.1075Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
BIOPSYBELL S.A.S.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K011075Device Name
EASYBELLManufacturer
Date Cleared
2001-06-27
(79 days)
Product Code
Regulation Number
876.1075Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
BIOPSYBELL S.A.S.
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
K011104Device Name
OSTEOBELLManufacturer
Date Cleared
2001-05-31
(50 days)
Product Code
Regulation Number
876.1075Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
BIOPSYBELL S.A.S.
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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