FDA Registration
Active
🇺🇸 United States
Acumen Assisted Fluid Management (AFM) Software Feature
Reg #: 3032916632
·
FEI: 3032916632
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BECTON, DICKINSON AND COMPANY
- Registration Number
- 3032916632
- FEI Number
- 3032916632
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 17200 Laguna Canyon Rd
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233984
Owner / Operator
- Firm Name
- Becton, Dickinson and Company
- Operator Number
- 10093301
- Address
- 17200 Laguna Canyon Road
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Karen M O'Leary
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Adjunctive Open Loop Fluid Therapy Recommender | QMS | Class 2 | Cardiovascular | No | 2025-05-06 |
Proprietary Names
Acumen Assisted Fluid Management (AFM) Software Feature
AFM Feature with AFM Prompt Reclassifier algorithm (AFM PR algorithm)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility