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 Continuous Measurement Thermometer
510(k) Number K902912
Device Name THERMOSCAN-INSTANT THERMOMETER MODEL IR-4000
Applicant
Thermoscan, Inc.
6295 Ferris Sq., Suite G
San Diego,  CA  92121
Applicant Contact ROBERT P LACKEY
Correspondent
Thermoscan, Inc.
6295 Ferris Sq., Suite G
San Diego,  CA  92121
Correspondent Contact ROBERT P LACKEY
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/03/1990
Decision Date 07/24/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-