EEG NEUROAMP, MODEL CS10137— 510(k) K073557

Clearance details

Applicant

Corscience GmbH & Co. KG

Product code

Code HCC

Device class

Class 2

Regulation

21 CFR 882.5050

Advisory panel

Neurology

Date received

2007-12-19

Decision date

2008-02-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Erlangen, Bavaria, DE

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073557.