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 Nebulizer (Direct Patient Interface)
510(k) Number K251659
Device Name Mesh Nebulizer (H6)
Applicant
Qingdao Future Medical Technology Co., Ltd.
South B1 Bldg. E, #621 Jiushui Rd., Laoshan District
Qingdao,  CN 266000
Applicant Contact Xinxin Wang
Correspondent
Qingdao Future Medical Technology Co., Ltd.
South B1 Bldg. E, #621 Jiushui Rd., Laoshan District
Qingdao,  CN 266000
Correspondent Contact Xinxin Wang
Regulation Number868.5630
Classification Product Code
CAF  
Subsequent Product Codes
BYG   BYP  
Date Received05/30/2025
Decision Date 11/14/2025
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
-
-