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 System, Environmental Control, Powered
510(k) Number K890596
Device Name MED-A-CALL ASSIST DEVICE
Applicant
Silent Call Corp.
P.O. Box 16348
Clarkston,  MI  48016
Applicant Contact GEORGE J ELWELL
Correspondent
Silent Call Corp.
P.O. Box 16348
Clarkston,  MI  48016
Correspondent Contact GEORGE J ELWELL
Regulation Number890.3725
Classification Product Code
IQA  
Date Received01/27/1989
Decision Date 03/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-