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Electrocardiograph (74 DPS) #YM-102

by Sanyo Electric, Inc.

510(k) K822768

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 NumberK822768 Date4 Oct 1982ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

This device is an electrocardiograph that processes electrical signals transmitted through two or more electrodes and produces a visual display of the electrical activity generated by the heart. It is designed to capture and display cardiac electrical signals for diagnostic evaluation.

The device is supplied by Sanyo Electric, Inc. and is associated with FDA 510(k) authorization under number K822768. It falls under the DPS product code and was reviewed by the Cardiovascular advisory committee. The data reflects a traditional clearance type with a substantially equivalent decision.

Other devices from Sanyo Electric, Inc.