• 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 cuff, tracheal tube, inflatable
510(k) Number K180991
Device Name AG 100s
Hospitech Respiration Ltd.
20 Hamagshimim St. Kiryat Matalon
Petach Tikva,  IL 49348
Applicant Contact Yoram Levy
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact Yoram Levy
Regulation Number868.5750
Classification Product Code
Date Received04/16/2018
Decision Date 10/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No