LIFELINES TRACKIT

Standard Polysomnograph With Electroencephalograph

LIFELINES LTD.

The following data is part of a premarket notification filed by Lifelines Ltd. with the FDA for Lifelines Trackit.

Pre-market Notification Details

• Device ID: K010460
• 510k Number: K010460
• Device Name: LIFELINES TRACKIT
• Classification: Standard Polysomnograph With Electroencephalograph
• Applicant: LIFELINES LTD. PO BOX 4341 Crofton, MD 21114
• Contact: Crhistina Smith
• Correspondent: Crhistina Smith; LIFELINES LTD. PO BOX 4341 Crofton, MD 21114
• Product Code: OLV
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-02-16
• Decision Date: 2001-05-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05060275450691	K010460	000
05060275450219	K010460	000
05060275450202	K010460	000
05060275450196	K010460	000
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05060275450011	K010460	000
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05060275450325	K010460	000
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05060275450004	K010460	000