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 K944986
Device Name EMSEE LABS MODEL C
Applicant
EMSEE LAB OF FLORIDA
36141 US 19 N
PALM HARBOR,  FL  34684
Applicant Contact HARVEY L ROMANEK
Correspondent
EMSEE LAB OF FLORIDA
36141 US 19 N
PALM HARBOR,  FL  34684
Correspondent Contact HARVEY L ROMANEK
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/12/1994
Decision Date 12/30/1994
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
Predetermined Change
Control Plan Authorized		 No
-
-