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 Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K921516
Device Name P2900 X-RAY GENERATOR
Applicant
Precise Optics Photo Medic Equipment, Inc.
239 S. Fehr Way
Bay Shore,  NY  11706
Applicant Contact HANNINGTON
Correspondent
Precise Optics Photo Medic Equipment, Inc.
239 S. Fehr Way
Bay Shore,  NY  11706
Correspondent Contact HANNINGTON
Regulation Number892.1700
Classification Product Code
IZO  
Date Received03/31/1992
Decision Date 05/28/1992
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
-
-