SOLA, COUNTER-PULSATION, MODEL SECP-S


Device Classification Name

device, counter-pulsating, external

510(k) Number K022078
Device Name SOLA, COUNTER-PULSATION, MODEL SECP-S
Original Applicant
SOLA MEDICAL DEVICES, LLC
3722 ave sausalito
irvine, 
CA 
92606

Original Contact greg holland
Regulation Number 870.5225
Classification Product Code
DRN  
Date Received 06/26/2002
Decision Date 01/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No