Zmachine

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

CONSOLIDATED RESEARCH OF RICHMOND, INC

The following data is part of a premarket notification filed by Consolidated Research Of Richmond, Inc with the FDA for Zmachine.

Pre-market Notification Details

• Device ID: K142825
• 510k Number: K142825
• Device Name: Zmachine
• Classification: Automatic Event Detection Software For Polysomnograph With Electroencephalograph
• Applicant: CONSOLIDATED RESEARCH OF RICHMOND, INC 26250 EUCLID AVE SUITE 709 Euclid, OH 44132
• Contact: Richard Kaplan
• Correspondent: Richard Kaplan; CONSOLIDATED RESEARCH OF RICHMOND, INC 26250 EUCLID AVE SUITE 709 Euclid, OH 44132
• Product Code: OLZ
• Subsequent Product Code: OLV
• Subsequent Product Code: OMC
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-09-30
• Decision Date: 2015-01-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B5662000010	K142825	000