ADAM

Full-montage Standard Electroencephalograph

ASTRO-MED, INC.

The following data is part of a premarket notification filed by Astro-med, Inc. with the FDA for Adam.

Pre-market Notification Details

• Device ID: K033978
• 510k Number: K033978
• Device Name: ADAM
• Classification: Full-montage Standard Electroencephalograph
• Applicant: ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893
• Contact: Michael J Sullivan
• Correspondent: Michael J Sullivan; ASTRO-MED, INC. 600 EAST GREENWICH AVE. West Warwick, RI 02893
• Product Code: GWQ
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-12-23
• Decision Date: 2004-02-18
• Summary: summary