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510(k) Data Aggregation
K Number
K021246Device Name
SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3
Manufacturer
Date Cleared
2002-05-13
(24 days)
Product Code
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
SENSIDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Non-invasive monitoring of patient oxygen saturation (SpO₂), pulse rate, and plethysmographic pulse wave.
The SensAid sensors can be used for Adult, Pediatric and/or Neonate/Infant applications with the appropriate Disposable Positioning Tape (DPT) accessory.
Device Description
The SensAid SpO2 Sensors measure oxygen saturation (SpO2), pulse rate, and plethysmographic pulse wave. The self-adhesive, latex free Disposable Positioning Tape (DPT) accessories quickly, comfortably, and securely attach to a patient. When a DPT is properly positioned on the patient and the SpO2 Multi-Site Reusable sensor is connected to the DPT, the sensor light emitting diodes and detector are aligned to ensure proper sensor performance.
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K Number
K011974Device Name
SENSAID
Manufacturer
Date Cleared
2002-02-12
(232 days)
Product Code
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
SENSIDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Non-invasive monitoring of patient oxygen saturation (SpO₂), pulse rate, and plethysmographic pulse wave.
Should sensors can be used for Adult, Pediatric and/or Neonate/Infant applications with the appropriate DPT accessory.
Device Description
Not Found
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K Number
K010382Device Name
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
Manufacturer
Date Cleared
2001-03-01
(21 days)
Product Code
Regulation Number
868.1720Why did this record match?
Applicant Name (Manufacturer) :
SENSIDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K000700Device Name
SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
Manufacturer
Date Cleared
2000-08-31
(183 days)
Product Code
Regulation Number
868.1720Why did this record match?
Applicant Name (Manufacturer) :
SENSIDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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