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Found 4 results
510(k) Data Aggregation
K Number
K030917Device Name
GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130
Manufacturer
COLLINS MEDICAL, INC.
Date Cleared
2003-05-14
(51 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
COLLINS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EAGLE is intended to be used for diagnostic use in the treatment of pulmonary illnesses with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system. The EAGLE is indicated for use in: pulmonary function testing.
The Collins EAGLE (Diffusion Spirometer)is a Pulmonary Function Test System. is intended as a configurable, non-invasive pulmonary function tester (PFT) testing system. These tests are suitable for both pediatric and adult patient testing.
Device Description
The EAGLE is a configurable, non-invasive pulmonary function tester (PFT) testing system. It includes a pneumotach (single-screen bi-directional device), commercially available pressure transducers, and gas analyzers (fast-response Infrared analyzer for CO, CO2, and CH4, and an electrochemical sensor for O2). It operates on 115-240 VAC 50-60 Hz.
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K Number
K030464Device Name
GEM, MODEL 004110
Manufacturer
COLLINS MEDICAL, INC.
Date Cleared
2003-03-14
(30 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
COLLINS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GEM is intended to be used for diagnostic use in the treatment of pulmonary illnesses with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system.. The GEM is indicated for use in: pulmonary function testing.
The Collins GEM (Gas Exchange Module) is a Pulmonary Function Test System. is intended as a configurable, non-invasive pulmonary function tester (PFT). These tests are suitable for both pediatric and adult patient testing. Compatible with the Collins' Body Plethysmograph as an optional module.
Device Description
The GEM (Gas Exchange Module) is a configurable, non-invasive pulmonary function tester (PFT) testing system. It includes a spirometer (pneumotach), gas analyzers (infrared for CO, CO2, CH4 and electrochemical for O2), and associated electronics.
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K Number
K011344Device Name
INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400
Manufacturer
COLLINS MEDICAL, INC.
Date Cleared
2002-05-17
(380 days)
Product Code
BZC, BZG, CCM
Regulation Number
868.1880Why did this record match?
Applicant Name (Manufacturer) :
COLLINS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992743Device Name
COLLINS CPL
Manufacturer
COLLINS MEDICAL, INC.
Date Cleared
1999-09-13
(28 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
COLLINS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Collins CPL Pulmonary Function Test System is intended as a configurable, noninvasive pulmonary function testing (PFT), and exercise/nutritional/metabolic testing system. Complete plethysmography capabilities are an optional module. These tests are suitable for both pediatric and adult patient testing.
Device Description
Not Found
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