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510(k) Data Aggregation
K Number
K211084Device Name
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
Manufacturer
Shanghai Caremate Medical Device Co. Ltd
Date Cleared
2021-10-19
(190 days)
Product Code
DXQ, LDE
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Caremate Medical Device Co. Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
Device Description
The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. The proposed device is non-invasive, non-automated, non-sterile, reusable device. The proposed device is consisting of manometer, cuff, cuff bladder, inflation bulb and with/without stethoscope. There are eight models including CM-BPM, CM-BPM-S, CM-BPM-D, CM-BPM-R, CM-PBPM-1, CM-PBPM-2, CM-PBPM-3 and CM-PBPM-C. The differences of eight models are on the size and material of manometer, material of cuff bladder, material of inflation bulb and stethoscope type if the device has stethoscope.
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