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510(k) K994346

ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM by Sendx Medical, Inc. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2000
Date Received
December 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type

Other clearances by Sendx Medical, Inc.

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  • K051804 — ABL80 FLEX ANALYZER (November 1, 2005)
  • K973742 — SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM (December 3, 1997)

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