FDA 510(k) K110374 MAX PULSE SYSTEM
FDA 510(k) K110374 MAX PULSE SYSTEM
Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K110374
Device Name MAX PULSE SYSTEM
Applicant MEDICORE CO., LTD.
Regulation Number 870.2780
Classification Product Code JOM
Date Received 02/09/2011
Decision Date 06/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Total pages: 892
Fully redacted pages: 759
Content pages: 133
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