DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC

• K Number: K123188
• Device Name: DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC
• Manufacturer: DORNOCH MEDICAL SYSTEMS, INC.
• Date Cleared: 2013-03-04 ( 144 days)
• Product Code: JCX
• Regulation Number: 878.4780
• Type: Special
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The Dornoch Transposal Ultra System is self-powered suction / vacuum pump intended to collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.

Device Description

The Dornoch Transposal Ultra System is self-powered suction / vacuum pump.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for a device called the "Dornoch Ultra Suction System," which is a powered suction pump. This document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or study details as requested in the prompts.

Therefore, I cannot fulfill your request for this specific document.

Regulation Number and Section

§ 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.