ALICE 5

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Alice 5.

Pre-market Notification Details

• Device ID: K040595
• 510k Number: K040595
• Device Name: ALICE 5
• Classification: Automatic Event Detection Software For Polysomnograph With Electroencephalograph
• Applicant: RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 -8550
• Contact: Zita A Yurko
• Correspondent: Ned Devine; ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548
• Product Code: OLZ
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2004-03-08
• Decision Date: 2004-03-18
• Summary: summary

NIH GUDID Devices

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