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 chamber, hyperbaric
510(k) Number K022214
Device Name MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
Applicant
MECHIDYNE SYSTEMS, INC.
P.O. BOX 840661
HOUSTON,  TX  77284 -0661
Applicant Contact AUDREY L AARON
Correspondent
MECHIDYNE SYSTEMS, INC.
P.O. BOX 840661
HOUSTON,  TX  77284 -0661
Correspondent Contact AUDREY L AARON
Regulation Number868.5470
Classification Product Code
CBF  
Date Received07/08/2002
Decision Date 02/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-