510(k) K033657

MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V by Living Data Technologies Corporation — Product Code DRN

K033657 is an FDA 510(k) premarket notification submitted by Living Data Technologies Corporation for the device "MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V". The FDA issued a decision of Substantially Equivalent on December 19, 2003. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225. Living Data Technologies Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2003
Date Received
November 21, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Counter-Pulsating, External
Device Class
Class II
Regulation Number
870.5225
Review Panel
CV
Submission Type