PACETRAK PLUS

K954495 · Universal Medical, Inc. · DXH · Apr 22, 1996 · Cardiovascular

Device Facts

Record IDK954495
Device NamePACETRAK PLUS
ApplicantUniversal Medical, Inc.
Product CodeDXH · Cardiovascular
Decision DateApr 22, 1996
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.2920
Device ClassClass 2

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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