SATELLITE

Full-montage Standard Electroencephalograph

NICOLET BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Nicolet Biomedical, Inc. with the FDA for Satellite.

Pre-market Notification Details

• Device ID: K971331
• 510k Number: K971331
• Device Name: SATELLITE
• Classification: Full-montage Standard Electroencephalograph
• Applicant: NICOLET BIOMEDICAL, INC. 5225 VERONA RD. Madison, WI 53711
• Contact: Douglas E Pfrang
• Correspondent: Douglas E Pfrang; NICOLET BIOMEDICAL, INC. 5225 VERONA RD. Madison, WI 53711
• Product Code: GWQ
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-04-10
• Decision Date: 1997-06-25
• Summary: summary