STRATUSOCT WITH RNFL NORMATIVE DATABASE


Device Classification Name

ophthalmoscope, ac-powered

510(k) Number K030433
Device Name STRATUSOCT WITH RNFL NORMATIVE DATABASE
Applicant
CARL ZEISS MEDITEC INC
5160 hacienda dr.
dublin, 
CA 
94568

Applicant Contact r. michael crompton
Correspondent
CARL ZEISS MEDITEC INC
5160 hacienda dr.
dublin, 
CA 
94568

Correspodent Contact r. michael crompton
Regulation Number 886.1570
Classification Product Code
HLI  
Date Received 02/10/2003
Decision Date 05/01/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls