FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01


Device Classification Name

cable, transducer and electrode, patient, (including connector)

510(k) Number K080621
Device Name FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01
Applicant
EUROPEAN CUSTOM MANUFACTURING BV
220 river road
claremont, 
NH 
03743

Applicant Contact william greenrose
Correspondent
EUROPEAN CUSTOM MANUFACTURING BV
220 river road
claremont, 
NH 
03743

Correspodent Contact william greenrose
Regulation Number 870.2900
Classification Product Code
DSA  
Date Received 03/05/2008
Decision Date 04/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No