Flexiflo Quantum Enteral Pump
FDA 510(k) K944669 · Abbott Mfg., Inc.
510(k) numberK944669
Submission
- Device name
- Flexiflo Quantum Enteral Pump
- Applicant
- Abbott Mfg., Inc.
Columbus, OH, US - Received
- September 13, 1994
- Decision date
- July 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Flexiflo Quantum Enteral Pump cleared by the FDA?
Flexiflo Quantum Enteral Pump (K944669) received a 510(k) decision of Substantially Equivalent on July 24, 1995, 314 days after the submission was received.
What is the product code of K944669?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.