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510(k) K052611

ECP HEALTH SYSTEM, MODEL 2005 by Ecp Health, Inc. — Product Code DRN

K052611 is an FDA 510(k) premarket notification submitted by Ecp Health, Inc. for the device "ECP HEALTH SYSTEM, MODEL 2005". The FDA issued a decision of Substantially Equivalent on April 26, 2006. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2006
Date Received
September 22, 2005
Clearance Type
Traditional
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

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  • K152115 — Renew NCP-5 External Counterpulsation System (December 17, 2015)
  • K130439 — EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING (December 12, 2013)
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  • K050172 — CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 (March 31, 2005)

FDA data resources