• 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
510(k) Number K828049
Device Name ADR ULTRASOUND MC2 LARGE CART
Applicant
Adr Ultrasound
734 W. Alameda Dr.
Tempe,  AZ  85282
Correspondent
Adr Ultrasound
734 W. Alameda Dr.
Tempe,  AZ  85282
Date Received08/31/1982
Decision Date 09/29/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-