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 Refractometer, Ophthalmic
510(k) Number K861066
Device Name AR-1000 AUTOMATIC REFRACTOR
Applicant
NIDEK, INC.
2460 EMBARCADERO WAY
P.O.BOX 50488
PALO ALTO,  CA  94303
Applicant Contact JOHN BRATKOWSKY
Correspondent
NIDEK, INC.
2460 EMBARCADERO WAY
P.O.BOX 50488
PALO ALTO,  CA  94303
Correspondent Contact JOHN BRATKOWSKY
Regulation Number886.1760
Classification Product Code
HKO  
Date Received03/20/1986
Decision Date 04/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-