XLTEK SLEEP SYSTEM— 510(k) K022037

Clearance details

Applicant

Excel Tech. , Ltd.

Product code

Code OLV

Device class

Class 2

Regulation

21 CFR 882.1400

Advisory panel

Neurology

Date received

2002-06-24

Decision date

2002-09-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Oakville, CA

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