TE ME NA POLYSTIM NERVE STIMILATOR

• K Number: K990323
• Device Name: TE ME NA POLYSTIM NERVE STIMILATOR
• Manufacturer: TE ME NA S.A.R.L.
• Date Cleared: 2001-09-28 ( 969 days)
• Product Code: BXN
• Regulation Number: 868.2775
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

FOR NEAVE STIMULATION AND TOENTIFICATION FOR 26616 WAL ANESTHESIA

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Polystim Nerve Stimulator." It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, this document does NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The letter is primarily a regulatory approval stating that the device can be marketed. It does not include the technical study details one would expect to find when describing acceptance criteria and a study proving device performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study, as this information is not present in the provided text.

Regulation Number and Section

§ 868.2775 Electrical peripheral nerve stimulator.

(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).