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FDA 510(k) Application Details - K962473
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
510(K) Number
K962473
Device Name
System,Network And Communication,Physiological Monitors
Applicant
DATA CRITICAL CORPORATION
15222 DEL AMO AVE.
TUSTIN, CA 92780 US
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Contact
RAY PIZINGER
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MSX
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More FDA Info for this Product Code
Date Received
06/25/1996
Decision Date
11/06/1997
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K962473
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