FDA 510(k) Premarket Notification K033410: TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002

Submission Details & Decision

Normalized public record details for 510(k) notification K033410.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K033410

Applicant / Sponsor

Remote Diagnostic Technologies , Ltd.

Device Name

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002

Product Code

DXH

Decision Date

2004-03-05

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2003-10-27

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