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510(k) K053011

PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 by Bio Protech, Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2005
Date Received
October 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
Review Panel
CV
Submission Type

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