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510(k) Data Aggregation
K Number
K192966Device Name
FlowMet
Manufacturer
Date Cleared
2020-01-10
(79 days)
Product Code
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
Laser Associated Sciences, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FlowMet is a non-invasive probe that is affixed to the fingers or toes and intended to quantify tissue blood flow rate.
Device Description
The FlowMet™ is a non-invasive probe that is affixed to the fingers or toes and intended to quantify tissue blood flow rate. The FlowMet™ probe is affixed to the digit (finger or toe) using a medical tape that is wrapped around the digit. Light source (laser diode) and detector (CMOS camera) secured in ABS/PC housings which are affixed to the digit using medical tape. Light source and detector are oriented to allow transillumination of digit.
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K Number
K182494Device Name
FlowMet-R
Manufacturer
Date Cleared
2019-02-27
(169 days)
Product Code
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
Laser Associated Sciences, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FlowMet-R is a non-invasive probe that is affixed to the fingers or toes and intended to quantify tissue blood flow rate.
Device Description
The FlowMet-R™ is a non-invasive probe that is affixed to the fingers or toes and intended to quantify tissue blood flow rate. The FlowMet-R™ is a miniaturized clip-on probe, designed to be affixed to the fingers or toes. The FlowMet-R™'s clamshell housing blocks the laser output when not in use or when applied to a digit.
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