• 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 hysteroscope (and accessories)
510(k) Number K192100
Device Name Aveta Disposable Hysteroscope
Applicant
Meditrina, Inc.
1190 Saratoga Avenue, Suite 180
San Jose,  CA  95129
Applicant Contact Csaba Truckai
Correspondent
Meditrina, Inc.
1190 Saratoga Avenue, Suite 180
San Jose,  CA  95129
Correspondent Contact Csaba Truckai
Regulation Number884.1690
Classification Product Code
HIH  
Date Received08/05/2019
Decision Date 12/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-