• 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 airway, oropharyngeal, anesthesiology
510(k) Number K842605
Device Name RESPIRONICS VENT EASY OXYGEN ENRICHME
Applicant
RESPIRONICS, INC.
530 SECO RD.
monroeville,  PA  15146
Correspondent
RESPIRONICS, INC.
530 SECO RD.
monroeville,  PA  15146
Regulation Number868.5110
Classification Product Code
CAE  
Date Received07/05/1984
Decision Date 07/27/1984
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-