Tempus Pro Extended Features
by Remote Diagnostic Technologies Ltd.
510(k) K133988
Tempus Pro Extended Features is a Class II device made by Remote Diagnostic Technologies Ltd., cleared under FDA 510(k) K133988 on 16 May 2014, active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133988 | Date16 May 2014 | StatusActive |
Official records
- FDA 510(k) database K133988
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MWI
- FDA applicant
- Remote Diagnostic Technologies , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)).
- Welch Allyn, Inc. 901060 67MXXX-B by Welch Allyn, Inc.
- 3880 MRI Patient Monitoring System by Iradimed Corporation
- Airstrip Remote Patient Monitoring by AirStrip Technologies, Inc.
- Bedside Paediatric Early Warning System (BedsidePEWS) by Bedside Clinical Systems, Inc.
- VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR by Welch Allyn, Inc.
- Vector Event Grid Architecture (VEGA) System by Nuvon, Inc.
- DataCaptor by Capsule Technologie
- Star 55 by Larsen & Toubro Limited
- Omni Patent Monitors by Infinium Medical, Inc.
- Masimo Root Monitoring System by MASIMO CORPORATION
Other devices from Remote Diagnostic Technologies Limited
See all devices from Remote Diagnostic Technologies Limited →