RHA2020


Device Classification Name

ophthalmoscope, ac-powered

510(k) Number K111531
Device Name RHA2020
Applicant
ANNIDIS HEALTH SYSTEMS CORP.
2650 queensview drive
suite 245
ottawa, ontario, 

CA

k2b 8h6

Applicant Contact michael mcdonnell
Regulation Number 886.1570
Classification Product Code
HLI  
Subsequent Product Code
HKI  
Date Received 06/02/2011
Decision Date 07/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No