FDA 510(k) Premarket Notification K082718: TEMPUSIC PATIENT MONITOR

Submission Details & Decision

Normalized public record details for 510(k) notification K082718.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K082718

Applicant / Sponsor

Remote Diagnostic Technologies , Ltd.

Device Name

TEMPUSIC PATIENT MONITOR

Product Code

DXH

Decision Date

2008-10-10

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2008-09-17

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