• 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 Device, Temperature Measurement, Direct Contact, Powered
510(k) Number K822795
Device Name GABRIEL DIGITREND
Applicant
GABRIEL ENT.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GABRIEL ENT.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1570
Classification Product Code
HCS  
Date Received09/16/1982
Decision Date 10/08/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-