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510(k) Data Aggregation
K Number
K090465Device Name
DIGDOP ULTRASOUND SYSTEM
Manufacturer
THE NEWMAN GROUP, LLC
Date Cleared
2009-04-08
(44 days)
Product Code
ITX
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
THE NEWMAN GROUP, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal (CWD - N)
Peripheral Vascular (CWD - N)
Device Description
The system consists of a main body and one probe. The nominal 2 or 3 MHz probes are designed for fetal applications. The nominal 5 or 8MHz probes are designed for peripheral vascular applications.
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K Number
K061091Device Name
BABYBEAT CORDLESS
Manufacturer
THE NEWMAN GROUP, LLC
Date Cleared
2006-05-04
(15 days)
Product Code
KNG
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
THE NEWMAN GROUP, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (Mode of Operation: CWD)
Device Description
Not Found
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