TEMPUS PRO WITH ENHANCED FEATURES

FDA 510(k) Premarket Notification · Submission K133973 · Applicant: Remote Diagnostic Technologies , Ltd.

Public Record 510(k) Submission Decision Date: 2014-08-14 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K133973.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K133973

Applicant / Sponsor

Remote Diagnostic Technologies , Ltd.

Device Name

TEMPUS PRO WITH ENHANCED FEATURES

Product Code

QYW

Decision Date

2014-08-14

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Abbreviated

Third Party Flag

Date Received

2013-12-26

Related Establishments / Registrations

REMOTE DIAGNOSTIC TECHNOLOGIES LTD. Registration: 3003832357 View Registration
Katmai Health Services LLC Registration: 3012104670 View Registration
KATMAI INTEGRATED SOLUTIONS Registration: 3015997711 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.