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510(k) K972314

PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM by Diametrics Medical, Ltd. — Product Code CCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1997
Date Received
June 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1150
Review Panel
AN
Submission Type

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  • K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (November 16, 2001)
  • K983198 — TRENDCARE CALIBRATOR MODEL SCU 7007 (November 23, 1999)
  • K980380 — NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARA (July 14, 1999)
  • K981270 — IRMA BLOOD ANALYSIS SYSTEM (May 1, 1998)
  • K980523 — IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE (March 19, 1998)
  • 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)

Other clearances for product code CCC

  • K071165 — ISCALERT SENSOR SYSTEM (November 7, 2007)
  • K983198 — TRENDCARE CALIBRATOR MODEL SCU 7007 (November 23, 1999)
  • K953893 — PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (November 4, 1997)
  • K961790 — POINT-OF-CARE BLOOD GAS MONITOR SYSTEM (April 9, 1997)
  • K963935 — OLYMPUS CRITICAL CARE MONITORING SYSTEM (January 23, 1997)
  • K951094 — POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM (January 16, 1996)
  • K940188 — PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (November 13, 1995)
  • K931185 — SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE (October 21, 1993)
  • K901548 — BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (January 14, 1991)
  • K891013 — MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING (August 2, 1989)