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 Thermometer, Clinical Color Change
510(k) Number K863181
Device Name HEALTHCHECK THERM-STRIP
Applicant
Healthcheck Corp.
150 Sandbank Rd.
Cheshire,  CT  06410
Applicant Contact BALZER, JR.
Correspondent
Healthcheck Corp.
150 Sandbank Rd.
Cheshire,  CT  06410
Correspondent Contact BALZER, JR.
Regulation Number880.2900
Classification Product Code
FQZ  
Date Received08/19/1986
Decision Date 09/11/1986
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
-
-