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510(k) K011564

NEOLEAD by Neotech Products, Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2002
Date Received
May 21, 2001
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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