PHILIPS ECG LEADWIRE SET


Device Classification Name

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

510(k) Number K110287
Device Name PHILIPS ECG LEADWIRE SET
Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Applicant Contact peter schipelliti
Regulation Number 870.2900
Classification Product Code
DSA  
Date Received 01/31/2011
Decision Date 02/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party Yes

Combination Product

No