FDA 510(k) · Mortara Instrument
K141020: SURVEYOR S4 MOBILE MONITOR (Mortara Instrument, Inc.)
Mortara Instrument, Inc. received FDA 510(k) K141020 for SURVEYOR S4 MOBILE MONITOR, with a decision date of Dec 3, 2014 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K141020 |
|---|---|
| Pathway | 510(k) |
| Applicant | Mortara Instrument, Inc. |
| Device name | SURVEYOR S4 MOBILE MONITOR |
| Product code | DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation (21 CFR) | 870.2910 |
| Device class | Class 2 |
| Date received | Apr 21, 2014 |
| Decision date | Dec 3, 2014 |
| 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
The Surveyor S4 Mobile Monitor is indicated for use: • The Surveyor S4 mobile monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG signals. • The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit. • The Surveyor S4 mobile monitor is indicated for use in a clinical setting by a physician, or by trained personnel acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. • The Surveyor S4 mobile monitor is indicated for use to acquire and output electrocardiographic data. • The Surveyor S4 mobile monitor is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering real-time acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network. • The Mortara Li-Ion Battery Charger is intended for charging only the Mortara Rechargeable Li-Ion battery pack.
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
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.
Later records that cite K141020
- K160685 Surveyor S4 Mobile Monitor (Mortara Instrument, Aug 4, 2016, MHX)
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 DRG is "Transmitters And Receivers, Physiological Signal, Radiofrequency", class 2, 21 CFR 870.2910.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.