SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2

• K Number: K012266
• Device Name: SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
• Manufacturer: NATIONAL CUSTOM ENT., INC.
• Date Cleared: 2001-09-12 ( 56 days)
• Product Code: MRZ
• Regulation Number: 880.5725
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

Replacement battery pack for SHERWOOD 224, 324 FEEDING PUMP & SHERWOOD K524 INTRI-FLUSH This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Device Description

Replacement battery pack for SHERWOOD 224, 324 FEEDING PUMP & SHERWOOD K524 INTRI-FLUSH

AI/ML Overview

This document is a 510(k) premarket notification approval letter for a replacement battery pack. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot generate the requested information based on the provided text.

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).