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 K152276
Device Name Wing Smart FEVI and Peak Flow Meter
Applicant
Sparo, Inc.
911 Washington Ave., #809
Saint Louis,  MO  63101
Applicant Contact Mona Dean
Correspondent
Sparo, Inc.
911 Washington Ave., #809
Saint Louis,  MO  63101
Correspondent Contact Mona Dean
Regulation Number868.1860
Classification Product Code
BZH  
Date Received08/12/2015
Decision Date 06/03/2016
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
-
-