Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K012139
Device Classification Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
More FDA Info for this Device
510(K) Number
K012139
Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant
DRAEGER MEDICAL, INC.
3135 QUARRY RD.
TELFORD, PA 18969 US
Other 510(k) Applications for this Company
Contact
JAMES J BRENNAN
Other 510(k) Applications for this Contact
Regulation Number
868.1400
More FDA Info for this Regulation Number
Classification Product Code
CCK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/10/2001
Decision Date
01/17/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
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