Who is the manufacturer of ELMED RF-ALERT?

Elmed, Inc. submitted the Traditional clearance for ELMED RF-ALERT (K953271).

What is the FDA product code for ELMED RF-ALERT?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ELMED RF-ALERT?

510(k) clearance (submission type: Traditional).

ELMED RF-ALERT

K953271 · Elmed, Inc. · GEI · Jan 18, 1996 · General, Plastic Surgery

Device Facts

Record ID	K953271
Device Name	ELMED RF-ALERT
Applicant	Elmed, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Jan 18, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.