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510(k) K771263

RADIOMHTER OSM-2 HEMOXIMETER by The London Co. — Product Code GHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1977
Date Received
July 11, 1977
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

Other clearances by The London Co.

  • K802846 — TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. (December 17, 1980)
  • K801848 — ICA1 IONIZED CALCIUM ANALYZER (October 31, 1980)
  • K800224 — RADIOMETER ACID BASE LABORATORY-ABL-3 (February 22, 1980)
  • K780652 — HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (July 27, 1978)
  • K771444 — QUALICHECK TM (August 16, 1977)
  • K760229 — ACID BASE SYSTEM, RADIOMETER AUTOMATED (August 26, 1976)

Other clearances for product code GHS

  • K974805 — CO-STAT(TM) END TIDAL BREATH ANALYZER (March 11, 1998)
  • K910827 — ABL520 BLOOD GAS SYSTEM (July 9, 1991)
  • K790943 — TRISEDTA-BORATE ELECTROPHORESIS FILM AGA (June 22, 1979)
  • K770209 — ECOLYZER CARBOXIMETER (March 7, 1977)