SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT


Device Classification Name

tomography, optical coherence

510(k) Number K121993
Device Name SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
Applicant
HEIDELBERG ENGINEERING GMBH
2995 steven martin dr.
fairfax, 
VA 
22031

Applicant Contact diane horwitz, ph.d.
Correspondent
HEIDELBERG ENGINEERING GMBH
2995 steven martin dr.
fairfax, 
VA 
22031

Correspodent Contact diane horwitz, ph.d.
Regulation Number 886.1570
Classification Product Code
OBO  
Date Received 07/06/2012
Decision Date 10/25/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No