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510(k) K023414

MIDA ALGORITHM REV. B by Ortivus AB — Product Code DYC

K023414 is an FDA 510(k) premarket notification submitted by Ortivus AB for the device "MIDA ALGORITHM REV. B". The FDA issued a decision of Substantially Equivalent on December 5, 2003. The device falls under product code DYC (Vectorcardiograph), a Class II device regulated under 21 CFR 870.2400.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 5, 2003
Date Received: October 11, 2002
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Vectorcardiograph
Device Class: Class II
Regulation Number: 870.2400
Review Panel: CV
Submission Type