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510(k) K011238

RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM by Metracor Technologies, Inc. — Product Code LZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2002
Date Received
April 23, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Analytical Sampling
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type

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  • K920438 — VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM (October 22, 1993)
  • K882830 — INFUSION PUMP (December 30, 1988)