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 K040726
Device Name VENTLAB NASAL CPAP CANNULA
Applicant
Ventlab Corp.
2934 Hwy. 601 N.
Mocksville,  NC  27028
Applicant Contact ROBERT M KELLY
Correspondent
Ventlab Corp.
2934 Hwy. 601 N.
Mocksville,  NC  27028
Correspondent Contact ROBERT M KELLY
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/22/2004
Decision Date 06/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-