Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K212409
Device Classification Name
Apparatus, Nitric Oxide Delivery
More FDA Info for this Device
510(K) Number
K212409
Device Name
Apparatus, Nitric Oxide Delivery
Applicant
Airgas Therapeutics
12800 West Little York Road
Houston, TX 77041 US
Other 510(k) Applications for this Company
Contact
Steven Miller
Other 510(k) Applications for this Contact
Regulation Number
868.5165
More FDA Info for this Regulation Number
Classification Product Code
MRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/03/2021
Decision Date
06/30/2023
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact