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510(k) K935260

PHYSIOMETRIX CABLE ADAPTER MODIFICATION by Physiometrix, Inc. — Product Code IKD

K935260 is an FDA 510(k) premarket notification submitted by Physiometrix, Inc. for the device "PHYSIOMETRIX CABLE ADAPTER MODIFICATION". The FDA issued a decision of Substantially Equivalent on December 23, 1993. The device falls under product code IKD (Cable, Electrode), a Class II device regulated under 21 CFR 890.1175. Physiometrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1993
Date Received
November 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Electrode
Device Class
Class II
Regulation Number
890.1175
Review Panel
PM
Submission Type

Other clearances by Physiometrix, Inc.

  • K051874 — SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET (September 2, 2005)
  • K033999 — SEDLINE WITH FRONTAL PSI (February 6, 2004)
  • K020670 — MODEL 4310 PSARRAY2 EEG ELECTRODE (October 8, 2002)
  • K020671 — PSA4000 EEG MONITOR WITH FRONTAL PSI (October 4, 2002)
  • K001069 — MODEL 4000 EEG MONITOR WITH PSI (PSA4000) (June 30, 2000)
  • K001055 — MODEL 4300 PSARRAY EEG ELECTRODE SET (May 11, 2000)
  • K970942 — MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM (June 2, 1997)
  • K970694 — MODEL 1700, HYDRO PREP (May 14, 1997)
  • K962447 — EQUINOX DIGITAL EEG SYSTEM (December 12, 1996)
  • K962157 — MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM (November 25, 1996)

Other clearances for product code IKD

  • K070926 — ELECTRODE/EXTENSION CABLES, MODELS ATAR (June 7, 2007)
  • K992372 — THE LEADAWAY (October 13, 1999)
  • K873361 — LIFE-SPAN CABLE (November 9, 1987)
  • K834583 — CLEAR LEADS-RADIOTRANSPARENT WIRES (January 30, 1984)
  • K800934 — R2 ESU CABLE-ADAPTER MODELS 160,161 (May 20, 1980)

FDA data resources