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510(k) K981270

IRMA BLOOD ANALYSIS SYSTEM by Diametrics Medical, Inc. — Product Code CGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1998
Date Received
April 7, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion-Specific, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type

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  • K972314 — PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIO (December 19, 1997)
  • K974396 — IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MOD (December 18, 1997)
  • K970906 — PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 (September 23, 1997)
  • K945240 — IRMA BLOOD ANALYSIS SYSTEM (January 5, 1995)

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