MODIFICATION TO ZYMED HOLTER 2000


Device Classification Name

electrocardiograph, ambulatory, with analysis algorithm

510(k) Number K992197
Device Name MODIFICATION TO ZYMED HOLTER 2000
Applicant
ZYMED MEDICAL INSTRUMENTATION
20 north aviador st.
camarillo, 
CA 
93010

Applicant Contact gretel lumley
Correspondent
ZYMED MEDICAL INSTRUMENTATION
20 north aviador st.
camarillo, 
CA 
93010

Correspodent Contact gretel lumley
Regulation Number 870.2800
Classification Product Code
MLO  
Date Received 06/30/1999
Decision Date 07/28/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized