SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL


Device Classification Name

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

510(k) Number K080605
Device Name SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL
Applicant
CURBELL ELECTRONICS INC.
20 centre dr.
orchard park, 
NY 
14127

Applicant Contact michael j winter
Correspondent
CURBELL ELECTRONICS INC.
20 centre dr.
orchard park, 
NY 
14127

Correspodent Contact michael j winter
Regulation Number 870.2900
Classification Product Code
DSA  
Date Received 03/04/2008
Decision Date 05/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No