CPD COMMANDER

• K Number: K974253
• Device Name: CPD COMMANDER
• Manufacturer: SCIERAN TECHNOLOGIES, INC.
• Date Cleared: 1998-02-25 ( 104 days)
• Product Code: MRH
• Regulation Number: 880.5725
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

Fluid/Gas Exchange and Viscous Fluid Delivery/Injection during ophthalmic surgery.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA to SCIERAN TECHNOLOGIES, INC. for their device, CPD COMMANDER. It states that the device is substantially equivalent to legally marketed predicate devices and can be brought to market. However, it does not contain the specific information requested about acceptance criteria or a study proving the device meets those criteria. The letter primarily addresses regulatory approval and classification.

Therefore, I cannot extract the requested information from 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).