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 Holder, Head, Radiographic
510(k) Number K843340
Device Name PORTA-STAT
Applicant
Porta-Stat, Inc.
35129 Dodge Park Rd.
Sterling Heights,  MI  48077
Applicant Contact JOHN L SPOLYAR
Correspondent
Porta-Stat, Inc.
35129 Dodge Park Rd.
Sterling Heights,  MI  48077
Correspondent Contact JOHN L SPOLYAR
Regulation Number892.1920
Classification Product Code
IWY  
Date Received08/27/1984
Decision Date 11/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-