FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

Device Name

BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC

Manufacturer

NATIONAL CUSTOM ENT., INC.

Date Cleared

2001-09-12

(56 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

Replacement battery pack for BAXTER AS40A & AS41 SYRINGE PUMP 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 BAXTER AS40A & AS41 SYRINGE PUMP

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a replacement battery pack, and it does not contain the details required to answer your request.

Summary

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).