PROSIM 4, PROSIM 6, PROSIM 8


Device Classification Name

monitor, cardiac (incl. cardiotachometer & rate alarm)

510(k) Number K110429
Device Name PROSIM 4, PROSIM 6, PROSIM 8
Applicant
FLUKE BIOMEDICAL
6045 cochran rd.
solon, 
OH 
44139

Applicant Contact john nelson
Correspondent
FLUKE BIOMEDICAL
6045 cochran rd.
solon, 
OH 
44139

Correspodent Contact john nelson
Regulation Number 870.2300
Classification Product Code
DRT  
Date Received 02/15/2011
Decision Date 09/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No