Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Tomography, Optical Coherence
510(k) Number K233933
Device Name CIRRUS™ HD-OCT Model 6000
Applicant
Carl Zeiss Meditec, Inc.
5300 Central Pkwy.
Dublic,  CA  94568
Applicant Contact Vidita Desai
Correspondent
Carl Zeiss Meditec, Inc.
5300 Central Pkwy.
Dublic,  CA  94568
Correspondent Contact Tanesha Bland
Regulation Number886.1570
Classification Product Code
OBO  
Date Received12/14/2023
Decision Date 05/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-