Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K031397
Device Classification Name
Valve, Non-Rebreathing
More FDA Info for this Device
510(K) Number
K031397
Device Name
Valve, Non-Rebreathing
Applicant
MERLIN MEDICAL LIMITED
THE WHITBREAD CENTRE,RHYMNEY,
GWENT
UNITED KINGDOM NP22 5BF GB
Other 510(k) Applications for this Company
Contact
ROBERT STEELE
Other 510(k) Applications for this Contact
Regulation Number
868.5870
More FDA Info for this Regulation Number
Classification Product Code
CBP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/02/2003
Decision Date
07/29/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact