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510(k) K003982

TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR by Magnetic Resonance Equipment Corp. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2001
Date Received
December 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by Magnetic Resonance Equipment Corp.

  • K983250 — INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR (December 12, 1999)
  • K954120 — MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR (April 2, 1997)
  • K924285 — MODEL 3500 MR-COMPATIBLE PULSE OXIMETER (May 11, 1993)
  • K924282 — MODEL 320 MR-COMPATIBLE PULSE OXIMETER (May 7, 1993)

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