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510(k) Data Aggregation
K Number
K991738Device Name
DIGITAL VIDEO RECORDING SYSTEM
Manufacturer
Date Cleared
1999-08-13
(84 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
KAY ELEMETRICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the DVRS is for viewing, acquiring, archiving and retrieving video images of endoscopic and fluoroscopic procedures. The images may be monochrome or color. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device.
Device Description
Digital Video Recording System (DVRS)
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K Number
K990240Device Name
ELECTROGLOTTOGRAPH
Manufacturer
Date Cleared
1999-03-11
(45 days)
Product Code
Regulation Number
874.1325Why did this record match?
Applicant Name (Manufacturer) :
KAY ELEMETRICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device use would be indicated in those cases where vocal fold contact information is considered helpful in evaluating physiologically normal speakers for research purposes or clinically in cases of vocal fold pathologies.
Device Description
Electroglottograph
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K Number
K954798Device Name
7100 SWALLOWING WORKSTATION
Manufacturer
Date Cleared
1996-06-04
(230 days)
Product Code
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
KAY ELEMETRICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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