BALANCED(TM) NYLON BLADDER

K930604 · Pymah Corp. · DXQ · Apr 30, 1993 · Cardiovascular

Device Facts

Record IDK930604
Device NameBALANCED(TM) NYLON BLADDER
ApplicantPymah Corp.
Product CodeDXQ · Cardiovascular
Decision DateApr 30, 1993
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.1120
Device ClassClass 2

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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