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510(k) Data Aggregation
K Number
K990403Device Name
TED 200T7 OXYGEN MONITOR
Manufacturer
Date Cleared
2000-02-03
(359 days)
Regulation Number
868.1720Why did this record match?
Applicant Name (Manufacturer) :
TELEDYNE ELECTRONIC TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TED 200T7 is intended to continuously measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.
Device Description
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K Number
K990457Device Name
TED 60T OXYGEN ANALYZER
Manufacturer
Date Cleared
1999-11-09
(270 days)
Product Code
Regulation Number
868.1720Why did this record match?
Applicant Name (Manufacturer) :
TELEDYNE ELECTRONIC TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TED 60T is intended to accurately measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and neonatal care. The TED 60T is intended for use only as a secondary measuring device to verify and spot check the concentration of oxygen in gas mixtures. The TED 60T should not be used as a primary monitoring device.
Device Description
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