FDA 510(k) Application Details - K962473

Device Classification Name System,Network And Communication,Physiological Monitors

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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
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Regulation Number 870.2300

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Classification Product Code MSX
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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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