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Found 4 results
510(k) Data Aggregation
K Number
K981220Device Name
SYSTEM 7500 ABC ELECTROSURGICAL UNIT
Manufacturer
ASPEN LABORATORIES, INC.
Date Cleared
1998-04-21
(18 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ASPEN LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Like the predicate devices, the proposed unit together with the same already marketed related predicate accessories is used for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.
Device Description
System 7500 Electrosurgical Unit
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K Number
K963088Device Name
SHEATH, ELECTROSURGICAL PENCIL
Manufacturer
ASPEN LABORATORIES, INC.
Date Cleared
1996-09-13
(36 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ASPEN LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955834Device Name
SYSTEM 6500 ABC ELECTROSURGICAL UNIT
Manufacturer
ASPEN LABORATORIES, INC.
Date Cleared
1996-07-11
(198 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ASPEN LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960296Device Name
4000 ETM
Manufacturer
ASPEN LABORATORIES, INC.
Date Cleared
1996-02-20
(29 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ASPEN LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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