BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01


Device Classification Name

tonometer, analyzer, ocular blood flow

510(k) Number K023245
Device Name BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
Original Applicant
PARADIGM MEDICAL INDUSTRIES, INC.
2355 south 1070 west
salt lake city, 
UT 
84119

Original Contact david m silver
Regulation Number 886.1930
Classification Product Code
NJJ  
Date Received 09/30/2002
Decision Date 10/21/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No