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Sign in to claim this brandIvy Biomedical Systems, Inc.
United States·US-MF-000001164
Last updated September 17, 2026
About
Ivy Biomedical Systems, Inc. is a privately-held medical device company headquartered in Branford, Connecticut. We are the market leader for precision cardiac gating monitors used for synchronization of radiographic image acquisition across all major modalities including nuclear medicine/molecular imaging (NM/MI), computed tomography (CT), magnetic resonance (MR), positron emission tomography (PET), and single photon emission computed tomography (SPECT).
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 11, Business Park Drive, Branford, United States
- Website
- www.ivybiomedical.com
- linkedin.com/company/3230983
- —
- [email protected]
- Phone
- +1 203-481-4183
- PRRC Contact
- Felicia Piel
- EUDAMED SRN
- US-MF-000001164
- FDA FEI Number
- 1221108
- DUNS Number
- —
Catalogue (289)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Model 7800 | 3300-18-15 | FDA UDI | Class II | Active |
| Model 7800 | 3304-06-15 | FDA UDI | Class II | Active |
| Model 7700 | 3607-04-15 | FDA UDI | Class II | Active |
| Model 7600 | 3303-20-15 | FDA UDI | Class II | Active |
| Model 405t With Etco2 Option | K964961 | FDA 510(k) | Class II | Active |
| Model 6000 Two Parameter Bedside Monitor | K091787 | FDA 510(k) | Class II | Active |
| Model 704 | K912139 | FDA 510(k) | Class II | Active |
| Model 303d And 403d Adult Heart Rate & Respirator | K880066 | FDA 510(k) | Class II | Active |
| MR Wireless Gating System, Model WGS-100 | K171778 | FDA 510(k) | Class II | Active |
| Physiological Monitor, Models 401, 402 & 403 | K862647 | FDA 510(k) | Class II | Active |
| Patient Monitor Model 701 | K884096 | FDA 510(k) | Class II | Active |
| Universal Physiological Measurement Module | K091985 | FDA 510(k) | Class II | Active |
| Patient Monitor Model 703 | K884662 | FDA 510(k) | Class II | Active |
| Physiological Monitor, Models 101, 301, 201, 202, 303a | K854840 | FDA 510(k) | Class II | Active |
| Parameters Monitores | K945099 | FDA 510(k) | Class II | Active |
| Model 2000 Pulse Oximeter | K982255 | FDA 510(k) | Class II | Active |
| Cardiac Trigger Monitor | K202138 | FDA 510(k) | Class II | Active |
| Physiological Monitor, Model 3000 (series) | K023616 | FDA 510(k) | Class II | Active |
| Model 700 Patient Monitor | K882118 | FDA 510(k) | Class II | Active |
| Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | K151781 | FDA 510(k) | Class II | Active |
| Cardiac Trigger, Model: Ctm300 | K083854 | FDA 510(k) | Class II | Active |
| Model 702 Ecg/Respiration/Temperature | K884455 | FDA 510(k) | Class II | Active |
| Models 706 Ecg/Pressure/Resp./Sao2, 705 Ecg/Resp. | K901504 | FDA 510(k) | Class II | Active |
| Patient Monitor Model 405p | K955546 | FDA 510(k) | Class II | Active |
| Cardiac Trigger Monitor | K170828 | FDA 510(k) | Class II | Active |
| Cardiac Trigger Monitor | K110987 | FDA 510(k) | Class II | Active |
| MRI ECG Patient Cable | K192852 | FDA 510(k) | Class II | Active |
| MRI PPG Patient Cable | K203653 | FDA 510(k) | Class II | Active |
| RT Carbon ECG Leads | K240087 | FDA 510(k) | Class II | Active |
| Model 404 Adult Heart Rate/Blood Pressure Monitor | K882188 | FDA 510(k) | Class II | Active |
| Model 405 | K904606 | FDA 510(k) | Class II | Active |
| Wgs-100 | 2802-03-01 | EUDAMED | Class I | Active |
| Wgs-100 | 3684-03-01 | EUDAMEDFDA UDI | Class I | Active |
| Wgs-100 | 3600-00-01 | EUDAMEDFDA UDI | Class I | Active |
| Wgs-100 | 4376-00-01 | EUDAMED | Class I | Active |
| Wgs-100 | 3647-01-01 | EUDAMEDFDA UDI | Class I | Active |
| Wgs-100 | 4094-00-01 | EUDAMEDFDA UDI | Class I | Active |
| Wgs-100 | 3750-01-01 | EUDAMEDFDA UDI | Class I | Active |
| Wgs-100 | 4162-01-15 | EUDAMEDFDA UDI | Class I | Active |
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