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

TPLC - Total Product Life Cycle
  • 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 show TPLC since Back to Search Results
Device system, test, breath nitric oxide
Product CodeMXA
Regulation Number 862.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
AEROCRINE AB
  SUBSTANTIALLY EQUIVALENT 4
  1.  K101034  NIOX MINO MODEL 09-1000
  2.  K123683  NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLA ...
  3.  K133898  NIOX VERO AIRWAY INFLAMMATION MONITOR
  4.  K150233  NIOX VERO Airway Inflammation Monitor
APIERON, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEDFONT SCIENTIFIC LTD
  SUBSTANTIALLY EQUIVALENT 1
BOSCH HEALTHCARE SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
CAIRE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
CIRCASSIA AB
  SUBSTANTIALLY EQUIVALENT 1
SPIROSURE, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 CAIRE DIAGNOSTICS INC II Mar-19-2021
-
-