Data / Medical devices / United States / Ivy Biomedical Systems, Inc.
Ivy Biomedical Systems, Inc.: FDA-registered device maker in Branford, CT, United States, 9 510(k) clearances
Ivy Biomedical Systems, Inc. is registered with the FDA (registration 1221108) in Branford, CT, United States. It lists 7 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 13, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1221108
- Address
- 11 Business Park DR., Branford, CT, United States, 06405
- Owner or operator
- IVY BIOMEDICAL SYSTEMS, INC. (1221108)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 21, 2009
- Registered through
- 2027
- Brand names listed
- 7600, 7700, 7800, Accessory Kit, 7600/7600EP, CTM-400, CTM300, Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor, Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Manufacturer | accessdata.fda.gov |
| Cardiovascular Procedure Kit | OEZ | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Synchronizer, Ecg / Respirator, Radiographic | IXO | 1 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 13, 2024 | K240087 | RT Carbon ECG Leads | DSA | Substantially Equivalent | Ivy Biomedical Systems, Inc. | accessdata.fda.gov |
| May 14, 2021 | K202138 | Cardiac Trigger Monitor | DRT | Substantially Equivalent | Ivy Biomedical Systems, Inc. | accessdata.fda.gov |
| March 2, 2021 | K203653 | MRI PPG Patient Cable | LNH | Substantially Equivalent | Ivy Biomedical Systems, Inc. | accessdata.fda.gov |
| March 28, 2020 | K192852 | MRI ECG Patient Cable | LNH | Substantially Equivalent | Ivy Biomedical Systems, Inc. | accessdata.fda.gov |
| March 14, 2018 | K171778 | MR Wireless Gating System, Model WGS-100 | LNH | Substantially Equivalent | Ivy Biomedical Systems, Inc. | accessdata.fda.gov |
| May 27, 2016 | K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | DRT | Substantially Equivalent | Ivy Biomedical Systems, Inc. | accessdata.fda.gov |
| July 22, 2011 | K110987 | CARDIAC TRIGGER MONITOR | DRT | Substantially Equivalent | Ivy Biomedical Systems, Inc. | accessdata.fda.gov |
| July 24, 2009 | K091985 | UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE | DRT | Substantially Equivalent | Ivy Biomedical Systems, Inc. | accessdata.fda.gov |
| February 13, 2009 | K083854 | CARDIAC TRIGGER, MODEL: CTM300 | DRT | Substantially Equivalent | Ivy Biomedical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Cardiovascular Procedure Kit
- All makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- All makers of Electrode, Electrocardiograph
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Updated September 13, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.