Infusa D.Slt Syringe Infusion Pump

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K904922 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K901953 Active Cleared 2 Jan 1991

• Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck Fractures

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• Cart, Multipurpose

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  FDA 510(k) K880539 Active Cleared 24 Feb 1988

• Dp 100

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• What is the Infusa D.Slt Syringe Infusion Pump used for?

  The Infusa D.Slt Syringe Infusion Pump is a Class II medical device designed for general hospital applications. It is intended for infusion therapy in hospital settings, providing precise medication delivery to patients.

• Is the Infusa D.Slt Syringe Infusion Pump single-use or reusable?

  The Infusa D.Slt Syringe Infusion Pump is supplied as either a single-use or reusable product, depending on the specific model configuration selected by the healthcare facility.

• What regulatory approvals does the Infusa D.Slt Syringe Infusion Pump have?

  The pump has received FDA 510(k) clearance with K-number K904922 and is regulated under product code FRN. It is classified as substantially equivalent to predicate devices for general hospital use.

• Is the Infusa D.Slt Syringe Infusion Pump MRI compatible?

  No, the Infusa D.Slt Syringe Infusion Pump is not MRI compatible. It requires appropriate storage conditions and should not be used in MRI environments.