FDA 510(k) Application Details - K190561

Device Classification Name	Computer, Oxygen-Uptake   More FDA Info for this Device
510(K) Number	K190561
Device Name	Computer, Oxygen-Uptake
Applicant	COSMED Nordic ApS Lucernemarken 23 Odense DK-5260 DK Other 510(k) Applications for this Company
Contact	Peter Clemensen Other 510(k) Applications for this Contact
Regulation Number	868.1730   More FDA Info for this Regulation Number
Classification Product Code	BZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2019
Decision Date	09/04/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review