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Isolated Electrocardiograph Model 1207

by Electronics For Medicine, Inc.

510(k) K770366

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 NumberK770366 Date1 Mar 1977ClearedStatusActive

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  • Withdrawn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
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Isolated Electrocardiograph Model 1207 is a Class II medical device classified under the nomenclature code DPS, designed as an electrocardiograph. It records the electrical activity of the heart to diagnose cardiac conditions by producing a graphical representation of the heart’s rhythm and electrical impulses. This device is intended for clinical use in monitoring and assessing cardiac function in patients.

The Model 1207 is supplied as a reusable medical instrument and is intended for use in healthcare settings such as hospitals and clinics. It is regulated under FDA 510(k) clearance (K770366) and falls under the Cardiovascular advisory committee review. No specific sterility or MRI safety information is provided in the available data, and its storage requirements are not detailed beyond standard medical device maintenance protocols.

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