FDA Registration
Active
🇺🇸 United States
UPMM
Reg #: 1221108
·
FEI: 1221108
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IVY BIOMEDICAL SYSTEMS, INC.
- Registration Number
- 1221108
- FEI Number
- 1221108
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11 BUSINESS PARK DR.
- City
- Branford
- State
- CT
- ZIP
- 06405
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091985
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 |
|---|---|---|---|---|---|
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2009-08-21 |
Proprietary Names
UPMM
Establishment Types
Manufacture Medical Device