FDA 510(k) Application Details - K213767

Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

  More FDA Info for this Device
510(K) Number K213767
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant Endure Industries Inc
45 N Fulton St
Homer, NY 13077 US
Other 510(k) Applications for this Company
Contact Manoj Kumar
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 12/01/2021
Decision Date 09/12/2023
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact