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510(k) Data Aggregation
K Number
K010465Device Name
DENSTAT
Manufacturer
Date Cleared
2001-05-14
(87 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K974793Device Name
ELMED ESU 120 M/M DIGITAL
Manufacturer
Date Cleared
1998-03-19
(87 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EIMED ESU 120 M/M DIGITAL is a electrosurgical system designed for surgical procedures to be chosen by licensed surgeons. The unit can be used for unipolar cutting, unipolar micro-coagulation and bimlar coagulation.
Device Description
ELMED ESU 120 M/M DIGITAL is an electrosurgical system.
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K Number
K953271Device Name
ELMED RF-ALERT
Manufacturer
Date Cleared
1996-01-18
(189 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ELMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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