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510(k) Data Aggregation
K Number
K083157Device Name
HS AMICA
Manufacturer
H.S HOSPITAL SERVICE S.P.A.
Date Cleared
2009-09-29
(340 days)
Product Code
NEY
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
H.S HOSPITAL SERVICE S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HS AMICA is intended for coagulation (thermoablation) of soft tissues. Not for use in cardiac procedures.
Device Description
HS AMICA (Apparatus for MICrowave Ablation) is an integrated system for interstitial thermoablation of soft tissues through controlled emission of microwaves. The system is composed by three interactive devices, namely: AMICA-GEN: a digitally controlled microwave power source, operating at 2450 MHz and delivering up to 100 W CW (continuous wave); it features a single output channel. AMICA-PROBE: an interstitial single-use coaxial microwave applicator, fed by AMICA--GEN. AMICA-PUMP: a peristaltic pump for convective applicator cooling through continuous circulation of liguid coolant, fully controlled by AMICA-GEN.
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K Number
K033616Device Name
TRAPMATIC SYSTEM SET
Manufacturer
H.S HOSPITAL SERVICE S.P.A.
Date Cleared
2004-03-01
(105 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
H.S HOSPITAL SERVICE S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This biopsy instrument is used for drawing of osteomedulary substance and or for explantation of bone marrow.
Device Description
Not Found
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