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 Meter, Peak Flow, Spirometry
510(k) Number K191239
Device Name Smart Peak Flow Meter
Applicant
Guangzhou Homesun Medical Technology Co., Ltd.
Floor 7th, Tianxiang Business Bldg., #28, Li Fu Rd.
Haizhu District
Guangzhou,  CN 510250
Applicant Contact Jinqun Li
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
B-3f 3005, Bldg.1, Southward Ruifeng Business Center, # 22
Guimiao Rd.
Shenzhen,  CN 518000
Correspondent Contact Tracy Che
Regulation Number868.1860
Classification Product Code
BZH  
Date Received05/08/2019
Decision Date 12/06/2019
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
-
-