FDA 510(k) Application Details - K233775

Device Classification Name	System,Test,Breath Nitric Oxide   More FDA Info for this Device
510(K) Number	K233775
Device Name	System,Test,Breath Nitric Oxide
Applicant	Bosch Healthcare Solutions GmbH Stuttgarter Strasse 130 Waiblingen 71332 DE Other 510(k) Applications for this Company
Contact	Carola D÷ffinger Other 510(k) Applications for this Contact
Regulation Number	862.3080   More FDA Info for this Regulation Number
Classification Product Code	MXA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/2023
Decision Date	02/22/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review