• 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 condenser, heat and moisture (artificial nose)
510(k) Number K934190
Device Name HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION
Applicant
BIRD LIFE DESIGN
4450 alpha rd.
dallas,  TX  75244 -4505
Applicant Contact ebecca d fuller
Correspondent
BIRD LIFE DESIGN
4450 alpha rd.
dallas,  TX  75244 -4505
Correspondent Contact ebecca d fuller
Regulation Number868.5375
Classification Product Code
BYD  
Date Received08/26/1993
Decision Date 11/24/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-