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 K023350
Device Name ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
Applicant
RESPIRONICS CALIFORNIA, INC.
2271 COSMOS CT.
CARLSBAD,  CA  92009
Applicant Contact MARY FUNK
Correspondent
RESPIRONICS CALIFORNIA, INC.
2271 COSMOS CT.
CARLSBAD,  CA  92009
Correspondent Contact MARY FUNK
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
BZG  
Date Received10/07/2002
Decision Date 11/06/2002
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
-
-