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 K243833
Device Name Portable oxygen concentrator (JAY-1000P)
Applicant
Longfian Scitech Co., Ltd.
2f&3f, E. Section, Bldg. 12, Power Valley Pioneer Park
#369 Huiyang St.
Baoding,  CN 071051
Applicant Contact Lei Shi
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg.,
1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/13/2024
Decision Date 09/29/2025
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
-
-