Ivy Biomedical Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 27
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240087 | RT Carbon ECG Leads | September 13, 2024 |
| K202138 | Cardiac Trigger Monitor | May 14, 2021 |
| K203653 | MRI PPG Patient Cable | March 2, 2021 |
| K192852 | MRI ECG Patient Cable | March 28, 2020 |
| K171778 | MR Wireless Gating System, Model WGS-100 | March 14, 2018 |
| K170828 | Cardiac Trigger Monitor | May 17, 2017 |
| K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | May 27, 2016 |
| K110987 | CARDIAC TRIGGER MONITOR | July 22, 2011 |
| K091787 | MODEL 6000 TWO PARAMETER BEDSIDE MONITOR | October 9, 2009 |
| K091985 | UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE | July 24, 2009 |
| K083854 | CARDIAC TRIGGER, MODEL: CTM300 | February 13, 2009 |
| K023616 | PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) | November 4, 2002 |
| K982255 | MODEL 2000 PULSE OXIMETER | October 22, 1998 |
| K964961 | MODEL 405T WITH ETCO2 OPTION | May 14, 1997 |
| K955546 | PATIENT MONITOR MODEL 405P | August 16, 1996 |
| K945099 | PARAMETERS MONITORES | July 13, 1995 |
| K912139 | MODEL 704 | March 25, 1992 |
| K904606 | MODEL 405 | March 1, 1991 |
| K901504 | MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP. | August 23, 1990 |
| K884455 | MODEL 702 ECG/RESPIRATION/TEMPERATURE | March 9, 1989 |