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K Number
K982371
Device Name
MEDCO ASPIRATOR IV
Manufacturer
MEDCO MFG.
Date Cleared
1999-02-12

(220 days)

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

A portable, AC powered suction pump to be used to remove infectious materials from wounds or fluids from a patients airway or respiratory Support system. The pump may be used during Surgery! • the operating room or at the patient bedside. The device includes a microbial

Device Description

A portable, AC powered suction pump

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) letter for the Medco Aspirator IV, specifically from pages 0, 1, and 2, does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This document is a clearance letter stating that the device is substantially equivalent to a predicate device and outlining regulatory information. It does not include the detailed technical study information you are requesting.

§ 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.