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 Conserver, Oxygen
510(k) Number K060751
Device Name INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
Applicant
INOVO, INC.
2975 S. HORSESHOE DRIVE
SUITE 600
NAPLES,  FL  34104
Applicant Contact MICHAEL T DILDINE
Correspondent
INOVO, INC.
2975 S. HORSESHOE DRIVE
SUITE 600
NAPLES,  FL  34104
Correspondent Contact MICHAEL T DILDINE
Regulation Number868.5905
Classification Product Code
NFB  
Date Received03/21/2006
Decision Date 07/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-