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510(k) K970694

MODEL 1700, HYDRO PREP by Physiometrix, Inc. — Product Code GYB

K970694 is an FDA 510(k) premarket notification submitted by Physiometrix, Inc. for the device "MODEL 1700, HYDRO PREP". The FDA issued a decision of Substantially Equivalent on May 14, 1997. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Physiometrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1997
Date Received
February 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
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)
  • K962447 — EQUINOX DIGITAL EEG SYSTEM (December 12, 1996)
  • K962157 — MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM (November 25, 1996)
  • K961609 — MODEL 1220, OR E-NET (54-62 CM) (May 10, 1996)

Other clearances for product code GYB

  • K243749 — Jmoon Conductive Gel (April 8, 2025)
  • K220735 — Avologi Gel Primer (Model: Av25) (September 15, 2023)
  • K222770 — Conductive Gel (December 13, 2022)
  • K221724 — Conductive Gel (September 23, 2022)
  • K212325 — EEG-acp (June 15, 2022)
  • K212326 — AC Cream - Conductive paste (December 1, 2021)
  • K212787 — GT5 conductive & abrasive gel (November 8, 2021)
  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
  • K191975 — Elefix V Paste for EEG & EMG (February 7, 2020)
  • K192606 — SAC2 - Electrode Cream (January 17, 2020)

FDA data resources