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 K010578
Device Name TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017
Applicant
TAGA MEDICAL TECHNOLOGIES, INC.
7561 TYLER BLVD.
UNIT 8
MENTOR,  OH  44060
Applicant Contact GARY AUSTIN
Correspondent
TAGA MEDICAL TECHNOLOGIES, INC.
7561 TYLER BLVD.
UNIT 8
MENTOR,  OH  44060
Correspondent Contact GARY AUSTIN
Regulation Number868.5450
Classification Product Code
BTT  
Date Received02/27/2001
Decision Date 04/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-