• 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 chamber, hyperbaric
510(k) Number K060739
Device Name MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
Applicant
KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR
PO BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL JAMM
Correspondent
KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR
PO BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL JAMM
Regulation Number868.5470
Classification Product Code
CBF  
Date Received03/20/2006
Decision Date 07/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-