BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1


Device Classification Name

electrocardiograph

510(k) Number K991831
Device Name BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
Applicant
BOSTON MEDICAL TECHNOLOGIES, INC.
591 north ave., suite 5
wakefield, 
MA 
01880 -1641

Applicant Contact donald broks
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 05/28/1999
Decision Date 06/11/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No