Search Results
Found 2 results
510(k) Data Aggregation
K Number
K051566Device Name
PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER
Manufacturer
Date Cleared
2006-01-17
(217 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
PROTON HEALTHCARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Proton Thermometer models PHC 8731, PHC 109 and PHC 889 are intended for measuring body temperature of all ages. The Proton Thermometers are reusable and intended for use in the home setting.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
K Number
K051565Device Name
PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA
Manufacturer
Date Cleared
2005-09-12
(90 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
PROTON HEALTHCARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
All five models automatically measures human's Systolic, Diastolic blood pressure and pulse rate, and output in one LCD Panel.
The intended use of Models PH168A, PH168E and PH168W is for age 16 and above.
The intended use for the Models PHC888JA and PH888HA is for adult patients whose arm circumference is between 24-32cm (approx. 8.7" to 12.6").
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1