MODEL 4810 ANALYZER OUTPUT ADAPTER


information about

Device Classification Name

analyzer, pacemaker generator function

510(k) Number K002497
Device Name MODEL 4810 ANALYZER OUTPUT ADAPTER
Original Applicant
PACE MEDICAL
391 totten pond rd.
waltham, 
MA 
02451

Original Contact robert c mace
Regulation Number 870.3630
Classification Product Code
DTC  
Date Received 08/14/2000
Decision Date 10/10/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No