GENESIS ECP


Device Classification Name

device, counter-pulsating, external

510(k) Number K081359
Device Name GENESIS ECP
Applicant
SCOTTCARE CORPORATION
4791 west 150th st.
cleveland, 
OH 
44135

Applicant Contact ronald j clines
Correspondent
SCOTTCARE CORPORATION
4791 west 150th st.
cleveland, 
OH 
44135

Correspodent Contact ronald j clines
Regulation Number 870.5225
Classification Product Code
DRN  
Date Received 05/15/2008
Decision Date 05/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No