FDA 510(k) · Telemedic Systems
K010732: VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM) (Telemedic Systems, Inc.)
Telemedic Systems, Inc. received FDA 510(k) K010732 for VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM), with a decision date of Sep 27, 2001 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K010732 |
|---|---|
| Pathway | 510(k) |
| Applicant | Telemedic Systems, Inc. |
| Device name | VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM) |
| Product code | MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Mar 12, 2001 |
| Decision date | Sep 27, 2001 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
We could not extract the indications for this record because FDA's summary PDF was not available at the usual address. Check the FDA record for its summary or statement.
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.