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510(k) Data Aggregation
K Number
K022865Device Name
6203
Manufacturer
Date Cleared
2003-02-13
(169 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
CONTEMPORARY PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 6203 is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
The Wave Conserver Model 6203 is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and use of a nasal cannula and USP bottled oxygen.
Device Description
The 6203 with integrated pressure regulator is intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The 6203 is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and a normally closed valve. When installed between the oxygen supply and patient's nasal cannula, the device detects the patient's inhalation, opens the valve according to the flow rate set on the device and delivers a preset bolus of oxygen to the patient as determined by the device flow rate algorithm. The valve closes and conserves the oxygen that would have been wasted during the end of inhalation and during exhalation.
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K Number
K992935Device Name
OCD2001
Manufacturer
Date Cleared
2000-06-20
(294 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
CONTEMPORARY PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OCD2001 is indicated for use to conserve oxygen for patients prescribed 1/2 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
Device Description
The OCD2001 is intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The OCD2001 is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and a normally closed valve. When installed between the oxygen supply and patient's nasal cannula, the device detects the patient's inhalation, opens the valve according to the flow rate set on the device and delivers a preset bolus of oxygen to the patient as determined by the device flow rate algorithm. The valve closes and conserves the oxygen that would have been wasted during the end of inhalation and during exhalation.
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K Number
K000543Device Name
CONTEMPRO-MIST
Manufacturer
Date Cleared
2000-06-16
(119 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
CONTEMPORARY PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964994Device Name
CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR
Manufacturer
Date Cleared
1997-02-21
(67 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
CONTEMPORARY PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K963558Device Name
CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR
Manufacturer
Date Cleared
1996-12-04
(90 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
CONTEMPORARY PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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