• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

  • 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 active noise attenuation system for infant incubators
De Novo Number DEN220048
Device Name Neoasis
Invictus Medical, Inc.
16601 blanco road
suite 120
san antonio,  TX  78232
Contact george hutchinson
Regulation Number880.5405
Classification Product Code
Date Received07/25/2022
Decision Date 06/16/2023
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Reclassification Order Reclassification Order
Type Direct