EAR MUFFINS

Device, Biofeedback

BIO-LOGIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Ear Muffins.

Pre-market Notification Details

• Device ID: K012384
• 510k Number: K012384
• Device Name: EAR MUFFINS
• Classification: Device, Biofeedback
• Applicant: BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700
• Contact: Norman E Brunner
• Correspondent: Norman E Brunner; BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein, IL 60060 -3700
• Product Code: HCC
• CFR Regulation Number: 882.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-07-27
• Decision Date: 2001-10-15
• Summary: summary