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 Ventilator, Non-Continuous (Respirator)
510(k) Number K071149
Device Name HRI 6500, 6600 AND 6700 SERIES V2MASKS
Applicant
Hans Rudolph, Inc.
7205 Central
Kansas City,  MO  64114
Applicant Contact KEVIN RUDOLPH
Correspondent
Hans Rudolph, Inc.
7205 Central
Kansas City,  MO  64114
Correspondent Contact KEVIN RUDOLPH
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/24/2007
Decision Date 02/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-