PHILIPS INTELLIVUE TCG10— 510(k) K110474

Clearance details

Applicant

Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

Product code

Code LKD

Device class

Class 2

Regulation

21 CFR 868.2480

Advisory panel

Anesthesiology

Date received

2011-02-18

Decision date

2011-09-30

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Boeblingen, Baden-Wuerttemberg, DE

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110474.