BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005


Device Classification Name

computer, diagnostic, programmable

510(k) Number K990956
Device Name BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005
Applicant
BIOSENSOR CORP.
11481 rupp dr.
burnsville, 
MN 
55337

Applicant Contact steve springrose
Correspondent
BIOSENSOR CORP.
11481 rupp dr.
burnsville, 
MN 
55337

Correspodent Contact steve springrose
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 03/22/1999
Decision Date 06/14/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No