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ECS 502

by Robert Bosch Corp.

510(k) K840717

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 NumberK840717 Date19 Aug 1985ClearedStatusActive

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  • Withdrawn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
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 ECS 502 is a Cardiac Monitor (Incl. Cardiotachometer & Rate Alarm) as defined by the FDA device classification. It is a Class II medical device intended for cardiovascular monitoring applications.

The device was cleared via the FDA 510(k) pathway under number K840717 with a traditional clearance type and substantially equivalent decision. It is manufactured by Robert Bosch Corp. and falls under product code DRT and regulation number 870.2300.

Other devices from Robert Bosch Corp.

See all devices from Robert Bosch Corp. →

Questions

AI-generated answers, 24 Sep 2026

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

  • What is the ECS 502 used for?

    The ECS 502 is intended for cardiovascular monitoring applications, providing continuous cardiac monitoring with integrated cardiotachometer and rate alarm functions to detect and alert on abnormal heart rates.

  • How was the ECS 502 cleared for market release?

    The ECS 502 received FDA clearance through the traditional 510(k) pathway under submission number K840717, with a substantially equivalent decision granted on August 19, 1985, based on its similarity to legally marketed predicate devices.

  • Who manufactures the ECS 502 and where is it produced?

    The ECS 502 is manufactured by Robert Bosch Corp. at their facility located at 803 N. Front St. Suite 3, McHenry, IL 60050, United States, as indicated in the device registration and listing information.