EMBLA

Standard Polysomnograph With Electroencephalograph

FERGUSON MEDICAL

The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Embla.

Pre-market Notification Details

• Device ID: K971813
• 510k Number: K971813
• Device Name: EMBLA
• Classification: Standard Polysomnograph With Electroencephalograph
• Applicant: FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619
• Contact: Frank Ferguson
• Correspondent: Frank Ferguson; FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619
• Product Code: OLV
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-05-16
• Decision Date: 1998-01-16
• Summary: summary