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Model SSR1 Holter Monitor

by Cardiodata Corp.

510(k) K873337

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 NumberK873337 Date9 Oct 1987ClearedStatusActive

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  • Withdrawn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
DSH
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Model SSR1 Holter Monitor is a magnetic tape recorder classified as a medical device under product code DSH. It is a cardiovascular recorder designed for ambulatory electrocardiographic monitoring.

It was cleared by the FDA through the traditional 510(k) pathway (K873337) on October 9, 1987, and is substantially equivalent to a predicate device. The device is manufactured by Cardiodata Corp. and is intended for use in clinical settings for cardiac monitoring.

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Questions

AI-generated answers, 6 Oct 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 Model SSR1 Holter Monitor used for?

    The Model SSR1 Holter Monitor is a cardiovascular recorder designed for ambulatory electrocardiographic monitoring in clinical settings, intended to record heart activity over time as a magnetic tape-based medical device under product code DSH.

  • How was the Model SSR1 Holter Monitor cleared for market?

    The Model SSR1 Holter Monitor was cleared by the FDA through the traditional 510(k) pathway under submission K873337 on October 9, 1987, and determined to be substantially equivalent to a predicate device, as indicated by its decision code SESE and clearance type Traditional.

  • Who manufactures the Model SSR1 Holter Monitor and where is it located?

    The Model SSR1 Holter Monitor is manufactured by Cardiodata Corp., located at 71 Lyman St., Northborough, MA 01532, United States, as specified in the device’s registration and applicant details.