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 hearing aid, air-conduction, prescription
510(k) Number K931942
Device Name RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P
Applicant
RESOUND CORP.
220 SAGINAW DRIVE,
SEAPORT CENTRE
REDWOOD CITY,  CA  94063
Applicant Contact JEANETTE JOHNSON
Correspondent
RESOUND CORP.
220 SAGINAW DRIVE,
SEAPORT CENTRE
REDWOOD CITY,  CA  94063
Correspondent Contact JEANETTE JOHNSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/19/1993
Decision Date 07/20/1993
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
-
-