Home / 510(k) Clearances / K946318

510(k) K946318

MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE by Physiometrix, Inc. — Product Code GXY

K946318 is an FDA 510(k) premarket notification submitted by Physiometrix, Inc. for the device "MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE". The FDA issued a decision of Substantially Equivalent on April 24, 1995. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Physiometrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1995
Date Received
December 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
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 GXY

  • K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/ (July 14, 2026)
  • K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electr (June 26, 2026)
  • K261522 — BioWave BioWraps (June 3, 2026)
  • K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) (May 8, 2026)
  • K254183 — MR Conditional Cup Electrodes (May 7, 2026)
  • K252439 — Tutamen Self Adhesive Electrodes (May 1, 2026)
  • K253256 — myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart (April 22, 2026)
  • K260363 — Ceribell Brain Monitor Headband (April 3, 2026)
  • K260453 — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (March 12, 2026)
  • K254033 — Ceribell Instant EEG Headset (February 9, 2026)

FDA data resources