FDA 510(k) Application Details - K210112

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K210112
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	Pneuma Therapeutics, Inc. 4090 E Bujia Primera Tucson, AZ 85718-6164 US Other 510(k) Applications for this Company
Contact	William Densel Other 510(k) Applications for this Contact
Regulation Number	868.1400   More FDA Info for this Regulation Number
Classification Product Code	CCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2021
Decision Date	01/30/2023
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