ALICE

Standard Polysomnograph With Electroencephalograph

HEALTHDYNE, INC.

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

Pre-market Notification Details

• Device ID: K922106
• 510k Number: K922106
• Device Name: ALICE
• Classification: Standard Polysomnograph With Electroencephalograph
• Applicant: HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274
• Contact: Tim Cowart
• Correspondent: Tim Cowart; HEALTHDYNE, INC. 1850 PARKWAY PLACE, 12TH FLOOR Marietta, GA 30067 -8274
• Product Code: OLV
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-05-05
• Decision Date: 1994-07-06