Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K121108
Device Classification Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
More FDA Info for this Device
510(K) Number
K121108
Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant
HUNTLEIGH HEALTHCARE
35 PORTMANMOOR ROAD
CARDIFF CF24 5HN GB
Other 510(k) Applications for this Company
Contact
DAVID MOYNHAM
Other 510(k) Applications for this Contact
Regulation Number
870.2780
More FDA Info for this Regulation Number
Classification Product Code
JOM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/12/2012
Decision Date
01/03/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact