510(k) K082173

Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S by Cardiac Science Corporation — Product Code DPS

K082173 is an FDA 510(k) premarket notification submitted by Cardiac Science Corporation for the device "Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S". The FDA issued a decision of Substantially Equivalent on August 26, 2008. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Cardiac Science Corporation has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2008
Date Received
August 1, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type