ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138

K011523 · Rossmax International , Ltd. · DXN · Jun 14, 2001 · Cardiovascular

Device Facts

Record IDK011523
Device NameROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138
ApplicantRossmax International , Ltd.
Product CodeDXN · Cardiovascular
Decision DateJun 14, 2001
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 870.1130
Device ClassClass 2

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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