TEMPUSIC PATIENT MONITOR— 510(k) K082718

Name: FDA 510(k) clearance K082718
Creator: U.S. Food and Drug Administration
Published: 2008-10-10

Substantially Equivalent

Remote Diagnostic Technologies , Ltd.

FDA 510(k) clearance K082718 for TEMPUSIC PATIENT MONITOR, Substantially Equivalent on 2008-10-10. Applicant: Remote Diagnostic Technologies , Ltd.. Device class: 2.

Clearance details

Applicant: Remote Diagnostic Technologies , Ltd.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2008-09-17
Decision date: 2008-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basingstoke, Hampshire, GB

Download summary PDF View on FDA.gov ↗

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