FDA 510(k) · Mortara Instrument
K160685: Surveyor S4 Mobile Monitor (Mortara Instrument, Inc.)
Mortara Instrument, Inc. received FDA 510(k) K160685 for Surveyor S4 Mobile Monitor, with a decision date of Aug 4, 2016 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K160685 |
|---|---|
| Pathway | 510(k) |
| Applicant | Mortara Instrument, Inc. |
| Device name | Surveyor S4 Mobile Monitor |
| Product code | MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Mar 11, 2016 |
| Decision date | Aug 4, 2016 |
| 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. Check the FDA record for its summary or statement.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary 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 MHX is "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.1025.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.