Surveyor Patient Monitor— 510(k) K173765
Substantially EquivalentMortara Instrument, Inc.
FDA 510(k) clearance K173765 for Surveyor Patient Monitor, Substantially Equivalent on 2018-09-04. Applicant: Mortara Instrument, Inc.. Device class: 2.
Clearance details
- Applicant
- Mortara Instrument, Inc.
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milwaukee, WI, US
Recent devices under product code MHX
view allMore clearances from Mortara Instrument, Inc.
view allAdverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K173765
K-number listed on FDA's recall record- Z-1484-2021 — Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
- Z-1816-2020 — Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW. The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable applications.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173765.
Data sourced from openFDA. This site is unofficial and independent of the FDA.