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510(k) K980380

NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS by Diametrics Medical, Ltd. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1999
Date Received
February 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

Other clearances by Diametrics Medical, Ltd.

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  • K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (November 16, 2001)
  • K983198 — TRENDCARE CALIBRATOR MODEL SCU 7007 (November 23, 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)
  • 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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