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 Cassette, Radiographic Film
510(k) Number K911041
Device Name INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE
Applicant
Invotec International, Inc.
11330-1st. John'S Industrial
Pkwy.
Jacksonville,  FL  32216
Applicant Contact JEFFREY L AULL
Correspondent
Invotec International, Inc.
11330-1st. John'S Industrial
Pkwy.
Jacksonville,  FL  32216
Correspondent Contact JEFFREY L AULL
Regulation Number892.1850
Classification Product Code
IXA  
Date Received03/08/1991
Decision Date 06/04/1991
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
-
-