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 Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K063488
Device Name MAXO2 CU
Applicant
MAXTEC, INC.
3460 POINTE CREEK CT.
# 102
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
MAXTEC, INC.
3460 POINTE CREEK CT.
# 102
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.1720
Classification Product Code
CCL  
Date Received11/17/2006
Decision Date 02/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-