510(k) K073557

EEG NEUROAMP, MODEL CS10137 by Corscience GmbH & Co. KG — Product Code HCC

K073557 is an FDA 510(k) premarket notification submitted by Corscience GmbH & Co. KG for the device "EEG NEUROAMP, MODEL CS10137". The FDA issued a decision of Substantially Equivalent on February 28, 2008. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Corscience GmbH & Co. KG has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2008
Date Received
December 19, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type