PATIENT CABLE


Device Classification Name

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

510(k) Number K080112
Device Name PATIENT CABLE
Applicant
MED-DYNE
2775 south floyd st.
louisville, 
KY 
40209

Applicant Contact e.w. johnson
Correspondent
MED-DYNE
2775 south floyd st.
louisville, 
KY 
40209

Correspodent Contact e.w. johnson
Regulation Number 870.2900
Classification Product Code
DSA  
Date Received 01/16/2008
Decision Date 06/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No