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, Non-Life-Supporting
510(k) Number K984407
Device Name BIPAP HARMONY S/T, MODEL 1001445
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Applicant Contact DAVID J VANELLA
Correspondent
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Correspondent Contact DAVID J VANELLA
Regulation Number868.5895
Classification Product Code
MNS  
Date Received12/09/1998
Decision Date 05/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-