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510(k) Data Aggregation
K Number
K061191Device Name
FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2
Manufacturer
Date Cleared
2006-05-22
(24 days)
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
MEASUREMENT SPECIALTIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Finger sensor: The Finger sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.
Ear sensor: The Ear sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 10 kg.
Neonatal-Adult sensor: The Neonatal-Adult sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
Adult/Pediatric Sensor: The Adult/Pediatric sensor for use with Nellcor® R-cal SpO2 is indicated for continuous, noninvasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing >= 20 kg.
Device Description
SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor body contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The sensor body is connected to a cable that is terminated with a 9-pin D-connector for connecting the sensor to a patient monitor or an interconnect cable.
The Finger and Ear sensors are durable, multiple-patient-use sensors. The sensor structure has a spring structure that easily and comfortably accomodates the sensor to the application site. The Neonatal-Adult and Adult/Pediatric sensors are disposable single-patient-use sensors. The attachment mechanism of these sensors is a soft adhesive tape that is wrapped around the application site.
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K Number
K010706Device Name
THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER
Manufacturer
Date Cleared
2001-10-05
(210 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
MEASUREMENT SPECIALTIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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