TGDC-01 PRA


Device Classification Name

tonometer, ac-powered

510(k) Number K021937
Device Name TGDC-01 PRA
Original Applicant
TRUEVISION INSTRUMENTS
4220 cesar chavez #536
san francisco, 
CA 
94131

Original Contact ralf thomaier
Regulation Number 886.1930
Classification Product Code
HKX  
Date Received 06/12/2002
Decision Date 10/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No