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 Punch, Biopsy
510(k) Number K894627
Device Name BT-338N ELECTRONIC CLINICAL THERMOMETER
Applicant
Integrated Display Technology, Ltd.
41, Man Yue St., Kaiser Estate
Block C, 9/F, Hung Hom,
Kowloon, Hong Kong,  HK
Applicant Contact CHAN (MRS.)
Correspondent
Integrated Display Technology, Ltd.
41, Man Yue St., Kaiser Estate
Block C, 9/F, Hung Hom,
Kowloon, Hong Kong,  HK
Correspondent Contact CHAN (MRS.)
Regulation Number876.1075
Classification Product Code
FCI  
Date Received07/24/1989
Decision Date 10/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-