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 K934450
Device Name MANHATTAN 3-CHANNEL
Applicant
ARGOSY ELECTRONICS
10300 WEST 70TH ST.
P.O. BOX 59072
EDEN PRAIRIE,  MN  55344
Applicant Contact DAVID A PREVES
Correspondent
ARGOSY ELECTRONICS
10300 WEST 70TH ST.
P.O. BOX 59072
EDEN PRAIRIE,  MN  55344
Correspondent Contact DAVID A PREVES
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/10/1993
Decision Date 10/08/1993
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
-
-