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 Spirometer, Therapeutic (Incentive)
510(k) Number K222018
Device Name Breathe+
Applicant
Peep Medical, LLC Dba Go2 Devices
9230 Katy Freeway, Suite 600
Houston,  TX  77055
Applicant Contact Paul Dryden
Correspondent
Peep Medical, LLC
131 Bay Point Dr.
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5690
Classification Product Code
BWF  
Date Received07/08/2022
Decision Date 06/02/2023
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
-
-