MERCURY MEDICAL CPR BAG EXHALATION FILTER

• K Number: K954490
• Device Name: MERCURY MEDICAL CPR BAG EXHALATION FILTER
• Manufacturer: MERCURY MEDICAL
• Date Cleared: 1996-10-03 ( 372 days)
• Product Code: CAH
• Regulation Number: 868.5260
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: K883693 , K951484 , K953687 , K911622 , K851070
• Predicate For: N/A

Intended Use

Not Found

Device Description

This device is the combination of two previously cleared devices: the Mercury Medical CPR Resuscitator (K911622) with Filter manufactured by Medicomp (K851070), which has been subsequently tested and supported with independent laboratory data for BFE and VFE.

AI/ML Overview

I am sorry, but the provided text is a summary of the 510(k) safety and effectiveness information for a medical device called "Mercury CPR Bag with Filter." It describes the device, its components, and mentions that it's a combination of previously cleared devices with independent laboratory data for BFE and VFE.

However, the text does not contain any information about a study that reports acceptance criteria, device performance metrics (like sensitivity, specificity, or accuracy), sample sizes for test or training sets, expert qualifications, ground truth establishment, or any details about AI/ML models or comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input. The document is a regulatory summary, not a study report.

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).