ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105


Device Classification Name

nasopharyngoscope (flexible or rigid)

510(k) Number K080622
Device Name ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105
Applicant
OPTIM, INC.
64 technology park rd.
sturbridge, 
MA 
01566 -1262

Applicant Contact robert krupa
Correspondent
OPTIM, INC.
64 technology park rd.
sturbridge, 
MA 
01566 -1262

Correspodent Contact robert krupa
Regulation Number 874.4760
Classification Product Code
EOB  
Date Received 03/05/2008
Decision Date 04/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No