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, continuous, facility use
510(k) Number K092648
Device Name RESPIRONICS PERFORMAX SE TOTAL FACE MASK
Applicant
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1740 GOLDEN MILE HWY
MONROEVILLE,  PA  15146
Applicant Contact ZITA A YURKO
Correspondent
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
1740 GOLDEN MILE HWY
MONROEVILLE,  PA  15146
Correspondent Contact ZITA A YURKO
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/28/2009
Decision Date 12/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-