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 Monitor, Esophageal Motility, Anorectal Motility, And Tube
510(k) Number K882551
Device Name AMBULATORY PH DATA RECORDER SYSTEM, APH-2000
Applicant
Intl. Biomedics, Inc.
7651 Airport Blvd.
Houston,  TX  77061
Applicant Contact BENNO L DUNN
Correspondent
Intl. Biomedics, Inc.
7651 Airport Blvd.
Houston,  TX  77061
Correspondent Contact BENNO L DUNN
Regulation Number876.1725
Classification Product Code
KLA  
Date Received06/21/1988
Decision Date 10/12/1988
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
-
-