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 K180770
Device Name Propeller Sensor for Neohaler
Applicant
Reciprocal Labs Corporation
634 West Main St.
Madison,  WI  53703
Applicant Contact David Hubanks
Correspondent
Reciprocal Labs Corporation
634 West Main St.
Madison,  WI  53703
Correspondent Contact Taylor Mahan-Rudolph
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/23/2018
Decision Date 08/01/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-