FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXIFLO QUANTUM ENTERAL PUMP
K Number: K944669
·
Decision Jul 24, 1995
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
14
Review Days
314
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
- FLEXIFLO QUANTUM ENTERAL PUMP
- K Number
- K944669
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Abbott Mfg., Inc.
- Date Received
- September 13, 1994
- Decision Date
- July 24, 1995
- 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
Other Clearances by Abbott Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981457 | ALBP | May 27, 1998 | Substantially Equivalent |
| K981232 | CA | May 18, 1998 | Substantially Equivalent |
| K981231 | CO2 | May 12, 1998 | Substantially Equivalent |
| K965230 | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP | Jul 3, 1997 | Substantially Equivalent |
| K971293 | LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE | Jun 27, 1997 | Substantially Equivalent |
| K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) | Oct 3, 1995 | Substantially Equivalent |
| K953657 | ABBOTT AXSYM PROLACTIN(MODIFICATION) | Sep 25, 1995 | Substantially Equivalent |
| K943691 | IMX FOLATE | Mar 23, 1995 | Substantially Equivalent |
| K943733 | FLEXIFLO SIX ENTERAL NUTRITION PUMP | Dec 12, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K941214 | LIFESHIELD EXTENSION SET | Oct 3, 1994 | Substantially Equivalent |