510(k) K073323

SA-3000P by Medicore Co., Ltd. — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2007
Date Received
November 27, 2007
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