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K Number
K971749
Device Name
EASYGO ASPIRATOR
Manufacturer
PRECISION MEDICAL, INC.
Date Cleared
1998-04-01

(324 days)

Product Code
BTA
Regulation Number
878.4780
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The EASy So Aspirator PROVIDES A PORTABLE, BATTERY POWER MEDICAL VALUAM SOLICE. THE EXELLIGO ASPIRATOR CAN ALSO BE POWERED FRIM A STANDARD WALL GUTLET WITH THE USE OF IN AC POWER ADAPTER. IT IS INTENDED FOR USE IN THE HOME CARE OF HOSPITAL ENVIRONMENT

Device Description

Not Found

AI/ML Overview

I am sorry, but without a study or performance data, I cannot provide information on acceptance criteria or device performance. The provided document is a 510(k) clearance letter from the FDA for a device called "EasyGo Aspirator" and does not contain the details of a study or performance metrics. It indicates that the device is substantially equivalent to legally marketed predicate devices, but it does not include a table of acceptance criteria or reported device performance.

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.