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, Alarm, Electrosurgical
510(k) Number K843214
Device Name EPHAR
Applicant
Akron City Hospital
525 E. Market St.
Akron,  OH  44309
Applicant Contact TIMOTHY A BODNER
Correspondent
Akron City Hospital
525 E. Market St.
Akron,  OH  44309
Correspondent Contact TIMOTHY A BODNER
Regulation Number876.4300
Classification Product Code
FFI  
Date Received08/15/1984
Decision Date 11/29/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-