• 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 Tester, Auditory Impedance
510(k) Number K850007
Device Name ACOUSTIC OTOCOPE RECORDER
Applicant
ENDECO MEDICAL, INC.
13 ATLANTIS DR.
MARION,  MA  02738
Applicant Contact RUSSELL N CHUTE
Correspondent
ENDECO MEDICAL, INC.
13 ATLANTIS DR.
MARION,  MA  02738
Correspondent Contact RUSSELL N CHUTE
Regulation Number874.1090
Classification Product Code
ETY  
Date Received01/02/1985
Decision Date 03/01/1985
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
-
-