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 Tent, Oxygen
510(k) Number K895866
Device Name DIRD INGANT O2 (BIO 2 HOOD)
Applicant
Bird Products Corp.
1100 Bird Center Dr.
Palm Spring,  CA  92262
Applicant Contact W. C BENTINCK
Correspondent
Bird Products Corp.
1100 Bird Center Dr.
Palm Spring,  CA  92262
Correspondent Contact W. C BENTINCK
Regulation Number868.5700
Classification Product Code
BYL  
Date Received10/04/1989
Decision Date 10/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-