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510(k) K051960

CARDIONAVIGATOR + by Del Mar Reynolds Medical, Ltd. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2005
Date Received
July 19, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

Other clearances by Del Mar Reynolds Medical, Ltd.

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  • K040313 — HRV TOOLS (April 6, 2004)

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