Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K100777
Device Classification Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
More FDA Info for this Device
510(K) Number
K100777
Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant
RADIOMETER MEDICAL APS
AKANDEVEJ 21
BRONSHOJ DK-2700 DK
Other 510(k) Applications for this Company
Contact
ROWENA JANSSON
Other 510(k) Applications for this Contact
Regulation Number
862.1120
More FDA Info for this Regulation Number
Classification Product Code
CHL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/18/2010
Decision Date
12/10/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact