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 System, X-Ray, Stationary
510(k) Number K870300
Device Name BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75
Applicant
Belmont Equipment Corp.
One Belmont Dr.
Somerset,  NJ  08873
Applicant Contact JOHN M GARDELLA
Correspondent
Belmont Equipment Corp.
One Belmont Dr.
Somerset,  NJ  08873
Correspondent Contact JOHN M GARDELLA
Regulation Number892.1680
Classification Product Code
KPR  
Date Received01/28/1987
Decision Date 03/25/1987
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
-
-