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510(k) K974805

CO-STAT(TM) END TIDAL BREATH ANALYZER by Natus Medical, Inc. — Product Code GHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1998
Date Received
December 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Carboxyhemoglobin
Device Class
Class II
Regulation Number
864.7425
Review Panel
HE
Submission Type

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Other clearances for product code GHS

  • K910827 — ABL520 BLOOD GAS SYSTEM (July 9, 1991)
  • K790943 — TRISEDTA-BORATE ELECTROPHORESIS FILM AGA (June 22, 1979)
  • K771263 — RADIOMHTER OSM-2 HEMOXIMETER (August 3, 1977)
  • K770209 — ECOLYZER CARBOXIMETER (March 7, 1977)