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 K945446
Device Name BOBES TONOMETER
Applicant
BOBES S.A.
CTRA. FUENTE DEL TORO, S/N
28710 EL MOLAR
MADRID,  ES
Applicant Contact FRANCISCO J BOBES NAVES
Correspondent
BOBES S.A.
CTRA. FUENTE DEL TORO, S/N
28710 EL MOLAR
MADRID,  ES
Correspondent Contact FRANCISCO J BOBES NAVES
Regulation Number886.1930
Classification Product Code
HKY  
Date Received11/07/1994
Decision Date 06/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-