FDA 510(k) Premarket Notification K133988: TEMPUS PRO EXTENDED FEATURES

Submission Details & Decision

Normalized public record details for 510(k) notification K133988.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K133988

Applicant / Sponsor

Remote Diagnostic Technologies , Ltd.

Device Name

TEMPUS PRO EXTENDED FEATURES

Product Code

MWI

Decision Date

2014-05-16

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Abbreviated

Third Party Flag

Date Received

2013-12-26

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