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 K980365
Device Name GOODKNIGHT 418 CPAP SYSTEM
Applicant
NELLCOR PURITAN BENNETT, INC.
2800 NORTHWEST BLVD.
MINNEAPOLIS,  MN  55441 -2625
Applicant Contact STEPHEN THEISSEN
Correspondent
NELLCOR PURITAN BENNETT, INC.
2800 NORTHWEST BLVD.
MINNEAPOLIS,  MN  55441 -2625
Correspondent Contact STEPHEN THEISSEN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/29/1998
Decision Date 07/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-