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Found 5 results
510(k) Data Aggregation
K Number
K122857Device Name
HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
Manufacturer
PEGASUS RESEARCH CORP.
Date Cleared
2012-11-07
(50 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PEGASUS RESEARCH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Res-Q Continuous Nebulizer is a device to used under the medical supervision in hospital, nursing homes, extended care facilities and outpatient clinics. The Res-Q Continuous Nebulizer is a high output nebulizer to be used to deliver aerosolized medications and diagnostic formulations. It provides additional hydration to help loosen secretions for patients whom extended therapy is required. Patient population: Asthma, pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, or other appropriate medications would be nebulized. The Res-Q Continuous Nebulizer requires 50 psig source gas. HE air or oxygen may be added via Multi-gas inlet.
Device Description
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K Number
K020700Device Name
PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
Manufacturer
PEGASUS RESEARCH CORP.
Date Cleared
2004-04-26
(784 days)
Product Code
BTT
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
PEGASUS RESEARCH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PMH Humidifier is intended to add moisture and To warm the breathing gases for administration to a patient. The humidifier is intended for use with flows of 5 liters per Minute or more through the humidifier.
Device Description
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K Number
K013856Device Name
PMH 1000 HEATED HUMIDIFIER
Manufacturer
PEGASUS RESEARCH CORP.
Date Cleared
2003-02-21
(472 days)
Product Code
BTT
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
PEGASUS RESEARCH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PMH 1000 Heated Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.
Device Description
Not Found
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K Number
K983783Device Name
HEATED HUMIDIFIER
Manufacturer
PEGASUS RESEARCH CORP.
Date Cleared
2000-10-24
(728 days)
Product Code
BTT, DAT
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
PEGASUS RESEARCH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Patient End Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.
Device Description
Not Found
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K Number
K962534Device Name
THERA-MIST NEBULIZER MODEL-P3000
Manufacturer
PEGASUS RESEARCH CORP.
Date Cleared
1997-02-28
(245 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PEGASUS RESEARCH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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