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 Audiometer
510(k) Number K940999
Device Name PRODIGIT 2000
Applicant
CALMED TECHNOLOGY, INC.
29411 KOHOUTEK WAY
UNION CITY,  CA  94587
Applicant Contact LISA S JONES
Correspondent
CALMED TECHNOLOGY, INC.
29411 KOHOUTEK WAY
UNION CITY,  CA  94587
Correspondent Contact LISA S JONES
Regulation Number874.1050
Classification Product Code
EWO  
Date Received03/04/1994
Decision Date 04/22/1994
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
-
-