SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT— 510(k) K121993

Name: FDA 510(k) clearance K121993
Creator: U.S. Food and Drug Administration
Published: 2012-10-25

Substantially Equivalent

Heidelberg Engineering GmbH

FDA 510(k) clearance K121993 for SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT, Substantially Equivalent on 2012-10-25. Applicant: Heidelberg Engineering GmbH. Device class: 2.

Clearance details

Applicant: Heidelberg Engineering GmbH
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2012-07-06
Decision date: 2012-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfax, VA, US

Download summary PDF View on FDA.gov ↗

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