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510(k) K903710

WASHINGTON CARDIAC MONITOR by Washington Biolab, Inc. — Product Code DXK

K903710 is an FDA 510(k) premarket notification submitted by Washington Biolab, Inc. for the device "WASHINGTON CARDIAC MONITOR". The FDA issued a decision of Substantially Equivalent on November 9, 1990. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1990
Date Received
August 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echocardiograph
Device Class
Class II
Regulation Number
870.2330
Review Panel
CV
Submission Type

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FDA data resources