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510(k) K970906

PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR by Diametrics Medical, Ltd. — Product Code CBZ

K970906 is an FDA 510(k) premarket notification submitted by Diametrics Medical, Ltd. for the device "PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR". The FDA issued a decision of Substantially Equivalent on September 23, 1997. The device falls under product code CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1170. Diametrics Medical, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1997
Date Received
March 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1170
Review Panel
AN
Submission Type

Other clearances by Diametrics Medical, Ltd.

  • K030035 — IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE (June 25, 2003)
  • K013938 — IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE (January 28, 2002)
  • 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)
  • 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)
  • K945240 — IRMA BLOOD ANALYSIS SYSTEM (January 5, 1995)

Other clearances for product code CBZ

  • K020967 — TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM (June 20, 2002)
  • K931112 — MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI (June 1, 1993)
  • K920061 — HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM (March 30, 1992)
  • K912030 — CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED (October 30, 1991)
  • K912428 — PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT (August 9, 1991)
  • K884228 — CDI(R) 2000 BLOOD GAS MONITOR (January 30, 1989)
  • K862114 — KHURI REGIONAL TISSUE PH MONITOR (June 25, 1986)
  • K803260 — SENSOMAT MUSCLE/TISSUE PH (February 2, 1981)
  • K803014 — SENSOMAT (December 22, 1980)

FDA data resources