RHYTHMVIEW (TM)


Device Classification Name

computer, diagnostic, programmable

510(k) Number K110878
Device Name RHYTHMVIEW (TM)
Applicant
TOPERA, INC.
11445 e. via linda
suite 2, p.o. box 224
scottsdale, 
AZ 
85259

Applicant Contact ruchir sehra
Correspondent
TOPERA, INC.
11445 e. via linda
suite 2, p.o. box 224
scottsdale, 
AZ 
85259

Correspodent Contact ruchir sehra
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 03/30/2011
Decision Date 09/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No