Mortara Instrument, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 51
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1796-2015 | Class II | ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting | May 29, 2015 |
| Z-0110-2015 | Class II | Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for us | October 7, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K182297 | Surveyor S2 | January 24, 2019 |
| K173765 | Surveyor Patient Monitor | September 4, 2018 |
| K161517 | Mortara Surveyor Patient Monitor | January 11, 2017 |
| K161465 | CardioConfirm | September 3, 2016 |
| K160685 | Surveyor S4 Mobile Monitor | August 4, 2016 |
| K152626 | H3+ Holter Recorder | February 26, 2016 |
| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems | January 6, 2016 |
| K141020 | SURVEYOR S4 MOBILE MONITOR | December 3, 2014 |
| K133989 | AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM | November 25, 2014 |
| K141811 | MORTARA MONITORING WAVEFORM VIEWER | November 19, 2014 |
| K142105 | ELI 380 ELECTROCARDIOGRAPH | September 5, 2014 |
| K131929 | SURVEYOR CENTRAL STATION | December 3, 2013 |
| K123556 | MORTARA SURVEYOR PATIENT MONITOR | March 22, 2013 |
| K122073 | ELI 280 ELECTROCARDIOGRAPH | August 2, 2012 |
| K120865 | RSCRIBE ELECTROCARDIOGRAPH | July 19, 2012 |
| K102206 | ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 | February 18, 2011 |
| K101403 | ELI 250 ELECTROCARDIOGRAPH | July 2, 2010 |
| K101115 | ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 | June 18, 2010 |
| K100127 | ELI 230 ELECTROCARDIOGRAPH | April 16, 2010 |
| K093339 | ELI PC ELECTROCARDIOGRAPH | February 19, 2010 |