APPLANATION TONOMETER


Device Classification Name

tonometer, ac-powered

510(k) Number K023676
Device Name APPLANATION TONOMETER
Original Applicant
OPTILASA S.L.
338 arturo soria st.
madrid, 

ES

28033

Original Contact jose m bobes
Regulation Number 886.1930
Classification Product Code
HKX  
Date Received 11/01/2002
Decision Date 04/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No