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510(k) K953449

MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS by Physiometrix, Inc. — Product Code GWQ

K953449 is an FDA 510(k) premarket notification submitted by Physiometrix, Inc. for the device "MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS". The FDA issued a decision of Substantially Equivalent on October 12, 1995. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Physiometrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1995
Date Received
July 18, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

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 GWQ

  • K261604 — Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (June 13, 2026)
  • K260455 — New Wave System (March 13, 2026)
  • K233403 — Flexset System (April 30, 2024)
  • K231366 — Neuronaute Plus (November 9, 2023)
  • K221959 — Q21 (August 31, 2023)
  • K231457 — SPARK Scan (August 18, 2023)
  • K221963 — Cumulus Functional Neurophysiology Platform (April 27, 2023)
  • K230073 — Okti (February 9, 2023)
  • K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
  • K220056 — iSyncWave (August 10, 2022)

FDA data resources