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510(k) K853990

OSM3 HEMOXIMETER by Radiometer America, Inc. — Product Code JKS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1985
Date Received
September 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
Device Class
Class I
Regulation Number
862.3220
Review Panel
TX
Submission Type

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Other clearances for product code JKS

  • K951485 — AVOXIMETER 4000 (November 6, 1995)
  • K863825 — CO-OXIMETER SOLUTIONS (November 24, 1986)
  • K862253 — IL 482 CO-OXIMETER (July 29, 1986)
  • K833693 — TEE ADAPTER 9890-FLUSH WINDING 282 (December 30, 1983)
  • K833211 — BILE SALTS MIXTURE (October 27, 1983)
  • K832066 — CONTROL 282 (September 29, 1983)
  • K780652 — HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (July 27, 1978)