DINAMAP PRO 1000 MONITOR, MODEL 1000


codes

Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K002248
Device Name DINAMAP PRO 1000 MONITOR, MODEL 1000
Original Applicant
CRITIKON COMPANY,LLC
4502 woodland corporate blvd.
tampa, 
FL 
33614

Original Contact thomas j english
Regulation Number 870.1130
Classification Product Code
DXN  
Subsequent Product Codes
BZQ   DQA   DRT   DSF   DSJ  
DSK   FLL  
Date Received 07/25/2000
Decision Date 09/21/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No