NEUROMETER

Device, Vibration Threshold Measurement

NEUROTRON, INC.

The following data is part of a premarket notification filed by Neurotron, Inc. with the FDA for Neurometer.

Pre-market Notification Details

• Device ID: K853608
• 510k Number: K853608
• Device Name: NEUROMETER
• Classification: Device, Vibration Threshold Measurement
• Applicant: NEUROTRON, INC. 6211 FALLS RD. Baltimore, MD 21209 -2107
• Contact: Jefferson Katims
• Correspondent: Jefferson Katims; NEUROTRON, INC. 6211 FALLS RD. Baltimore, MD 21209 -2107
• Product Code: LLN
• CFR Regulation Number: 882.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-08-28
• Decision Date: 1986-06-12