• 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 ventilatory effort recorder
510(k) Number K203343
Device Name Wesper Lab
Wesper Inc.
234 5th Avenue
New York,  NY  10001
Applicant Contact Amir Reuveny
Wesper Inc.
234 5th Avenue
New York,  NY  10001
Correspondent Contact Amir Reuveny
Regulation Number868.2375
Classification Product Code
Subsequent Product Code
Date Received11/13/2020
Decision Date 12/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No