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510(k) K973742

SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM by Sendx Medical, Inc. — Product Code CGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1997
Date Received
October 1, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion-Specific, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

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