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 accessory, assisted reproduction
510(k) Number K013703
Device Name SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
Applicant
SANYO NORTH AMERICA CORP.
900 N. ARLINGTON HEIGHTS RD.
SUITE 310
TASCA,  IL  60143 -2844
Applicant Contact SACHI KATAOKA
Correspondent
SANYO NORTH AMERICA CORP.
900 N. ARLINGTON HEIGHTS RD.
SUITE 310
TASCA,  IL  60143 -2844
Correspondent Contact SACHI KATAOKA
Regulation Number884.6120
Classification Product Code
MQG  
Date Received11/08/2001
Decision Date 12/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-