ACTIWATCH

Full-montage Standard Electroencephalograph

MINI-MITTER CO., INC.

The following data is part of a premarket notification filed by Mini-mitter Co., Inc. with the FDA for Actiwatch.

Pre-market Notification Details

• Device ID: K983533
• 510k Number: K983533
• Device Name: ACTIWATCH
• Classification: Full-montage Standard Electroencephalograph
• Applicant: MINI-MITTER CO., INC. PO BOX 3386 Sunriver, OR 97707
• Contact: Jack E Mckenzie
• Correspondent: Jack E Mckenzie; MINI-MITTER CO., INC. PO BOX 3386 Sunriver, OR 97707
• Product Code: GWQ
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-10-08
• Decision Date: 1999-03-23
• Summary: summary