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510(k) Data Aggregation
K Number
K203085Device Name
NOVA Patient Warming System
Manufacturer
Date Cleared
2020-11-12
(30 days)
Product Code
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
Encompass Group, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NOVA Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. It should be used in circumstances in which patients may not maintain a state of normothermia.
It is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors.
Not for use in home health care environment
Device Description
Not Found
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K Number
K982058Device Name
ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN
Manufacturer
Date Cleared
1999-01-14
(217 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
ENCOMPASS GROUP, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Device Description
A reusable surgical gown fabricated from 99% polyester, 1% carbon, chemically treated fabric and designed to provide fluid protection through up to 150 laundry/sterilization cycles.
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K Number
K982059Device Name
ROTECNO 2000 SURGICAL GOWN
Manufacturer
Date Cleared
1998-11-30
(172 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
ENCOMPASS GROUP, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Device Description
A reusable surgical gown fabricated from 99% polyester, 1% carbon, chemically treated fabric and designed to provide fluid protection through up to 150 laundry/sterilization cycles.
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