MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS— 510(k) K953449

Name: FDA 510(k) clearance K953449
Creator: U.S. Food and Drug Administration
Published: 1995-10-12

Substantially Equivalent

Physiometrix, Inc.

FDA 510(k) clearance K953449 for MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS, Substantially Equivalent on 1995-10-12. Applicant: Physiometrix, Inc.. Device class: 2.

Clearance details

Applicant: Physiometrix, Inc.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1995-07-18
Decision date: 1995-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Billerica, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWQ

view all

K261604 — Enobio Dx (3 models)2026-06-13
K260455 — New Wave System2026-03-13
K233403 — Flexset System2024-04-30
K231366 — Neuronaute Plus2023-11-09
K221959 — Q212023-08-31

More clearances from Physiometrix, Inc.

view all

K051874 — SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET2005-09-02
K033999 — SEDLINE WITH FRONTAL PSI2004-02-06
K020670 — MODEL 4310 PSARRAY2 EEG ELECTRODE2002-10-08
K020671 — PSA4000 EEG MONITOR WITH FRONTAL PSI2002-10-04
K001069 — MODEL 4000 EEG MONITOR WITH PSI (PSA4000)2000-06-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.