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 Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K950582
Device Name SULLIVAN PASSOVER HUMIDIFER
Applicant
Rescare, Inc.
6044 Cornerstone Ct.W.,
Suite C
San Diego,  CA  92121
Applicant Contact CONSTANCE G BUNDY
Correspondent
Rescare, Inc.
6044 Cornerstone Ct.W.,
Suite C
San Diego,  CA  92121
Correspondent Contact CONSTANCE G BUNDY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received02/09/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-