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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

K980380 is an FDA 510(k) premarket notification submitted by Diametrics Medical, Ltd. for the device "NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS". The FDA issued a decision of Substantially Equivalent on July 14, 1999. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Diametrics Medical, Ltd. has at least 10 other 510(k) clearances on record.

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.

  • 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)
  • 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)

Other clearances for product code GWM

  • K252241 — Pressio 3 Multi-parameter Neuromonitoring System (April 10, 2026)
  • K250285 — NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); (August 29, 2025)
  • K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (July 18, 2024)
  • K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (February 4, 2024)
  • K201989 — B4C System (October 8, 2021)
  • K210993 — CereLink ICP Monitor (April 30, 2021)
  • K201118 — Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Ex (May 26, 2020)
  • K200630 — Medtronic External Drainage and Monitoring System, Medtronic External Drainage a (April 9, 2020)
  • K200456 — Becker External Drainage and Monitoring System (March 26, 2020)
  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)

FDA data resources