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 Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K132857
Device Name RESPIRATORY GAS HUMIDIFIER
Applicant
Pacific Medico Co., Ltd.
2-6-4 Hongo
Bunkyo-Ku, Tokyo,  JP 113-0033
Applicant Contact YOSHIO TOYAMA
Correspondent
Pacific Medico Co., Ltd.
2-6-4 Hongo
Bunkyo-Ku, Tokyo,  JP 113-0033
Correspondent Contact YOSHIO TOYAMA
Regulation Number868.5450
Classification Product Code
BTT  
Date Received09/12/2013
Decision Date 05/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-