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 K020700
Device Name PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
Applicant
PEGASUS RESEARCH CORP.
1714 SOUTH LYON ST.
SANTA ANA,  CA  92705
Applicant Contact KENNETH G MILLER
Correspondent
PEGASUS RESEARCH CORP.
1714 SOUTH LYON ST.
SANTA ANA,  CA  92705
Correspondent Contact KENNETH G MILLER
Regulation Number868.5450
Classification Product Code
BTT  
Date Received03/04/2002
Decision Date 04/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-