Lifelines Trackit

FDA 510(k) K010460 · Lifelines , Ltd.

Substantially Equivalent

510(k) numberK010460

Submission

Device name
Lifelines Trackit
Applicant
Lifelines , Ltd.
Crofton, MD, US
Received
February 16, 2001
Decision date
May 14, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
OLV – Standard Polysomnograph With Electroencephalograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Specialty
Neurology

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

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Questions and answers

When was Lifelines Trackit cleared by the FDA?

Lifelines Trackit (K010460) received a 510(k) decision of Substantially Equivalent on May 14, 2001, 87 days after the submission was received.

What is the product code of K010460?

The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.