XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40— 510(k) K991900

Clearance details

Applicant

Excel Tech. , Ltd.

Product code

Code OLV

Device class

Class 2

Regulation

21 CFR 882.1400

Advisory panel

Neurology

Date received

1999-06-04

Decision date

1999-07-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Oakville,Ontario, CA

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