FDA 510(k) Premarket Notification K010436: TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011

Submission Details & Decision

Normalized public record details for 510(k) notification K010436.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K010436

Applicant / Sponsor

Remote Diagnostic Technologies , Ltd.

Device Name

TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011

Product Code

DXH

Decision Date

2001-05-14

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2001-02-13

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