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510(k) K110374

MAX PULSE SYSTEM by Medicore Co., Ltd. — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2011
Date Received
February 9, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
Submission Type

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