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SI2000 (Sense-It Trademark) or G2000; Disposable Resting Electrode

by Cmc Sense-It, Inc.

510(k) K955800

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955800 Date17 May 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRX
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a disposable resting electrode, specifically the SI2000 (SENSE-IT TRADEMARK) OR G2000 model, designed for use in cardiovascular monitoring applications. It is intended to detect and transmit electrical signals from the body during resting electrocardiogram procedures.

It is supplied as a single-use, non-sterile device and was cleared through the FDA 510(k) process under K955800 with a traditional clearance pathway. The device is not MRI safe unless explicitly stated, and no information on storage conditions, sizes, or reusability beyond disposable use is provided in the data.

Other devices from Cmc Sense-It, Inc.