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510(k) Data Aggregation
K Number
K991159Device Name
PRISMATHERM II, ASTOLINEManufacturer
Date Cleared
1999-09-03
(149 days)
Product Code
Regulation Number
864.9205Type
AbbreviatedPanel
HematologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
PRISMATHERM II, ASTOLINE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Warm return blood flow
Device Description
Not Found
AI/ML Overview
I'm sorry, but this document does not contain the information requested. The document appears to be an FDA 510(k) clearance letter for a device called "Prismatherm II." It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.
However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. These details would typically be found in the 510(k) submission itself, not directly in the clearance letter provided here.
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