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 K121770
Device Name HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
Applicant
Headstar Medical Products Co., Ltd.
9 F., # 8, Sec. 1,
Chung-Shan Rd., Hsin-Chang
City, Taipei County,  TW 242
Applicant Contact GLORIA CHEN
Correspondent
Headstar Medical Products Co., Ltd.
9 F., # 8, Sec. 1,
Chung-Shan Rd., Hsin-Chang
City, Taipei County,  TW 242
Correspondent Contact GLORIA CHEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/15/2012
Decision Date 04/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-