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 Mercury
510(k) Number K942483
Device Name CLINICAL GLASS THERMOMETER
Applicant
Makol Medical Instruments Corp.
3313 NW 74th Ave.
Miami,  FL  33122
Applicant Contact EDUARDO J MARTINEZ
Correspondent
Makol Medical Instruments Corp.
3313 NW 74th Ave.
Miami,  FL  33122
Correspondent Contact EDUARDO J MARTINEZ
Regulation Number880.2920
Classification Product Code
FLK  
Date Received05/25/1994
Decision Date 03/28/1995
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
-
-