• 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, carbon-dioxide, gaseous-phase
510(k) Number K031411
Device Name MINI STATCO2 CO2 DETECTOR, MODEL 10-55371
Applicant
MERCURY MEDICAL
11300 49TH ST. NORTH
CLEARWATER,  FL  33762 -4800
Applicant Contact WAYNE GLOVER
Correspondent
MERCURY MEDICAL
11300 49TH ST. NORTH
CLEARWATER,  FL  33762 -4800
Correspondent Contact WAYNE GLOVER
Regulation Number868.1400
Classification Product Code
CCK  
Date Received05/05/2003
Decision Date 07/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-