• 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 K911183
Device Name NHS 2044P BODY AID, HEARING AID
Applicant
MAGNATONE HEARING AID CORP.
170 N. CYPRESS WAY
P.O. BOX 180964
CASSELBERRY,  FL  32718 -0964
Applicant Contact TONY QUICK
Correspondent
MAGNATONE HEARING AID CORP.
170 N. CYPRESS WAY
P.O. BOX 180964
CASSELBERRY,  FL  32718 -0964
Correspondent Contact TONY QUICK
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/18/1991
Decision Date 07/09/1991
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
-
-