TEMPUS PRO WITH ENHANCED FEATURES— 510(k) K133973

Name: FDA 510(k) clearance K133973
Creator: U.S. Food and Drug Administration
Published: 2014-08-14

Substantially Equivalent

Remote Diagnostic Technologies , Ltd.

FDA 510(k) clearance K133973 for TEMPUS PRO WITH ENHANCED FEATURES, Substantially Equivalent on 2014-08-14. Applicant: Remote Diagnostic Technologies , Ltd.. Device class: 2.

Clearance details

Applicant: Remote Diagnostic Technologies , Ltd.
Product code: Code QYW
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2013-12-26
Decision date: 2014-08-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Basingstoke, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Remote Diagnostic Technologies , Ltd.

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K134014 — TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)2014-08-12
K133988 — TEMPUS PRO EXTENDED FEATURES2014-05-16
K130773 — TEMPUS PRO PATIENT MONITOR2013-06-05

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