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 tonometer, manual
510(k) Number K000288
Device Name REICHERT CT200 CONTACT TONOMETER
Applicant
REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC.
3374 WALDEN AVE.
DEPEW,  NY  14043
Applicant Contact FRANK J DREXELIUS
Correspondent
REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC.
3374 WALDEN AVE.
DEPEW,  NY  14043
Correspondent Contact FRANK J DREXELIUS
Regulation Number886.1930
Classification Product Code
HKY  
Date Received01/31/2000
Decision Date 03/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-