Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K052544
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K052544
Device Name
Oximeter
Applicant
AMERICAN I.V. PRODUCTS, INC.
7485 SHIPLEY AVE.
HANOVER, MD 21076 US
Other 510(k) Applications for this Company
Contact
GREGORY FALK
Other 510(k) Applications for this Contact
Regulation Number
870.2700
More FDA Info for this Regulation Number
Classification Product Code
DQA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/15/2005
Decision Date
09/29/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact