Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K070867
Device Classification Name
Apparatus, Nitric Oxide Delivery
More FDA Info for this Device
510(K) Number
K070867
Device Name
Apparatus, Nitric Oxide Delivery
Applicant
INO THERAPEUTICS LLC
6 ROUTE 173
CLINTON, NJ 08809 US
Other 510(k) Applications for this Company
Contact
RICHARD K BOURNE
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
03/29/2007
Decision Date
04/27/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact