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 Cradle, Patient, Radiologic
510(k) Number K933134
Device Name SPECTRUM DG-P7000 PEDIATRIC CRADLE
Applicant
Spectrum X-Ray Corp.
P.O. Box 155 Ryan Ave.
Westville,  NJ  08093
Applicant Contact ROBERT WELSH
Correspondent
Spectrum X-Ray Corp.
P.O. Box 155 Ryan Ave.
Westville,  NJ  08093
Correspondent Contact ROBERT WELSH
Regulation Number892.1830
Classification Product Code
KXH  
Date Received06/28/1993
Decision Date 10/07/1993
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
-
-