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510(k) Data Aggregation
K Number
K062724Device Name
ACCUPULSE PULSE OXIMETER
Manufacturer
Date Cleared
2007-05-11
(241 days)
Product Code
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
EAGLE MEDICAL EQUIPMENT CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Finger Pulse Oximeter is a small portable device that measures % SpO2, pulse rate, and pulse indication on the finger. It may be used as a spot-check device in the home or clinical environment. The pulse oximeter will provide reliable measurements on pediatric patients weighing 35 lbs or more, and on adult patients. This device is not intended for continuous patient monitoring. There are no audible or visible patient alarms.
Device Description
The AccuPulse Oximeter is a portable, lightweight, and battery-operated device that measures %SpO2 and pulse rate on the finger of a patient.
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K Number
K955129Device Name
OXYPULSE EOC I, EOC II & EOC R
Manufacturer
Date Cleared
1996-02-16
(99 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
EAGLE MEDICAL EQUIPMENT CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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