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 Generator, Oxygen, Portable
510(k) Number K033405
Device Name LONGFEI LFY-I-5 OXYGEN CONCENTRATOR
Applicant
Zhejiang Longfei Industrial Co., Ltd.
2288 Caoyang Rd.
Shanghai,  CN 200333
Applicant Contact COCO WANG
Correspondent
Zhejiang Longfei Industrial Co., Ltd.
2288 Caoyang Rd.
Shanghai,  CN 200333
Correspondent Contact COCO WANG
Regulation Number868.5440
Classification Product Code
CAW  
Date Received10/24/2003
Decision Date 10/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-