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510(k) K973991

METRON QA-510 SPO2 ANALYZER by Metron U.S., Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1998
Date Received
October 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Metron U.S., Inc.

  • K982020 — METRON QA-IDS I.V. PUMP TESTER (September 30, 1998)
  • K963190 — QA-40M DEFIBRILLATOR TESTER (July 1, 1997)
  • K963198 — PS-41 6M PATIENT SIMULATOR (March 5, 1997)

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  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
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