ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR


Device Classification Name

monitor, cardiac (incl. cardiotachometer & rate alarm)

510(k) Number K992411
Device Name ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
Applicant
MEDICAL DATA ELECTRONICS
12720 wentworth st.
arleta, 
CA 
91331

Applicant Contact david m trueblood
Correspondent
MEDICAL DATA ELECTRONICS
12720 wentworth st.
arleta, 
CA 
91331

Correspodent Contact david m trueblood
Regulation Number 870.2300
Classification Product Code
DRT  
Subsequent Product Codes
DQA   DTE  
Date Received 07/20/1999
Decision Date 08/18/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No