OSRAM ITOS


Device Classification Name

otoscope

510(k) Number K110326
Device Name OSRAM ITOS
Applicant
OSRAM SYLVANIA, INC.
1801 rockville pike
suite 300
rockville, 
MD 
20852

Applicant Contact marie a schroeder
Correspondent
OSRAM SYLVANIA, INC.
1801 rockville pike
suite 300
rockville, 
MD 
20852

Correspodent Contact marie a schroeder
Regulation Number 874.4770
Classification Product Code
ERA  
Date Received 02/03/2011
Decision Date 10/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No