FDA Registration
Active
🇺🇸 United States
IVY BIOMEDICAL SYSTEMS, INC.
Reg #: 1221108
·
FEI: 1221108
·
Expires 2026
Products
7
Proprietary Names
10
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- IVY BIOMEDICAL SYSTEMS, INC.
- Registration Number
- 1221108
- FEI Number
- 1221108
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11 BUSINESS PARK DR.
- City
- Branford
- State
- CT
- ZIP
- 06405
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151781
Owner / Operator
- Firm Name
- IVY BIOMEDICAL SYSTEMS, INC.
- Operator Number
- 1221108
- Address
- 11 BUSINESS PARK DR., --
- City
- Branford
- State
- CT
- Postal Code
- 06405
- Country
- US
- Correspondent
- Felicia - Piel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Synchronizer, Ecg / Respirator, Radiographic | IXO | Class 1 | Radiology | No | 2016-11-09 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2019-04-18 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2024-09-16 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2025-01-15 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2025-01-15 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2022-01-31 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-01-31 |
Proprietary Names
CTM-400
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
CTM300
UPMM
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Accessory Kit, 7600/7600EP
7700
7600
7800
RT Carbon ECG Leads
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198