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 Otoscope
510(k) Number K851745
Device Name 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B
Applicant
ARTIBERIA
4518 LOS RANCHITOS
SAN ANTONIO,  TX  78233
Applicant Contact GIL M SANCHEZ
Correspondent
ARTIBERIA
4518 LOS RANCHITOS
SAN ANTONIO,  TX  78233
Correspondent Contact GIL M SANCHEZ
Regulation Number874.4770
Classification Product Code
ERA  
Date Received04/25/1985
Decision Date 08/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-