FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER

Device Classification Name

tonometer, manual

510(k) Number

K991840

Device Name

FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER

Applicant

BERNARD B. FRESCO

40 saint clair ave east 303

toronto, ontario,

m4t 1m9

Applicant Contact

bernard b fresco

Correspondent

BERNARD B. FRESCO

40 saint clair ave east 303

toronto, ontario,

m4t 1m9

Correspodent Contact

bernard b fresco

Regulation Number

886.1930

Classification Product Code

HKY

Date Received

05/28/1999

Decision Date

03/20/2000

Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

Type

Traditional

Reviewed by Third Party

Combination Product