FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 3001 SYRINGE INFUSION PUMP
K Number: K901755
·
Decision Aug 29, 1990
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
5
Review Days
134
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODEL 3001 SYRINGE INFUSION PUMP
- K Number
- K901755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medfusion, Inc.
- Date Received
- April 17, 1990
- Decision Date
- August 29, 1990
- Product Code
- FRN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRN), ordered by most recent decision date.
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
FDA 510(k)
FDA Class 2
·General Hospital
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
FDA 510(k)
FDA Class 2
·General Hospital
SIGMA Spectrum Infusion Pump with Master Drug Library
FDA 510(k)
FDA Class 2
·General Hospital
MRidium 3870 MRI Infusion Pump System (3870)
FDA 510(k)
FDA Class 2
·General Hospital
BD Alaris Infusion System with Guardrails Suite MX
FDA 510(k)
FDA Class 2
·General Hospital
Plum Solo Precision IV Pump
FDA 510(k)
FDA Class 2
·General Hospital