FDA 510(k) · Telemedic Systems
K073094: VITALLINK3 MOBILE VITAL SIGNS SYSTEM (Telemedic Systems, Ltd.)
Telemedic Systems, Ltd. received FDA 510(k) K073094 for VITALLINK3 MOBILE VITAL SIGNS SYSTEM, with a decision date of Jan 4, 2008 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K073094 |
|---|---|
| Pathway | 510(k) |
| Applicant | Telemedic Systems, Ltd. |
| Device name | VITALLINK3 MOBILE VITAL SIGNS SYSTEM |
| Product code | MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Nov 1, 2007 |
| Decision date | Jan 4, 2008 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The VitalLink 3 Mobile Vital Signs Monitor is intended for use as a portable vital signs monitor for patients who are remotely located from medical professionals. The system can be used to acquire and display vital signs data from patients in remote locations and transmit that data, in real time, to eleMedic S,~$tens 2 --, 7"I A 7~~ , ,F E1 E W TeleMedic Systemxs Revision A 112307 medical professional located at a call centre / different location in order to help determine the patients transport needs.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MWI is "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.2300.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.