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 Monitor, Ultrasonic, Nonfetal
510(k) Number K904392
Device Name MULTILAB 2000
Applicant
Unetixs, Inc.
25 Reservoir Ave.
Providence,  RI  02907
Applicant Contact JOHN HAEFELE
Correspondent
Unetixs, Inc.
25 Reservoir Ave.
Providence,  RI  02907
Correspondent Contact JOHN HAEFELE
Regulation Number892.1540
Classification Product Code
JAF  
Date Received09/24/1990
Decision Date 04/29/1991
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
Recalls CDRH Recalls
-
-