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510(k) K982020

METRON QA-IDS I.V. PUMP TESTER by Metron U.S., Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1998
Date Received
June 9, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Metron U.S., Inc.

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  • K963190 — QA-40M DEFIBRILLATOR TESTER (July 1, 1997)
  • K963198 — PS-41 6M PATIENT SIMULATOR (March 5, 1997)

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