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 heater, breathing system w/wo controller (not humidifier or nebulizer
510(k) Number K894654
Device Name FLEXHTR-1
Applicant
BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Applicant Contact W.C BENTINCK
Correspondent
BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Correspondent Contact W.C BENTINCK
Regulation Number868.5270
Classification Product Code
BZE  
Date Received07/24/1989
Decision Date 08/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-