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 K070321
Device Name TWILIGHT FULL FACE MASK
Applicant
INVACARE CORP.
ONE INVACARE WAY
ELYRIA,  OH  44035 -4190
Applicant Contact CARROLL MARTIN
Correspondent
INVACARE CORP.
ONE INVACARE WAY
ELYRIA,  OH  44035 -4190
Correspondent Contact CARROLL MARTIN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received02/02/2007
Decision Date 04/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-