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Seismocardiograph - SCG 1000 Series

by Seismed Instruments, Inc.

510(k) K892323

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 NumberK892323 Date30 Oct 1989ClearedStatusActive

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  • Withdrawn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)

Full name
Seismocardiograph - Scg(Tm) 1000 Series
510(k) Number
FDA Product Code
DSB
Device Class
Class II
Regulation
21 CFR Part 870.2770
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Seismocardiograph - SCG 1000 Series is a plethysmograph, impedance device used for cardiovascular applications. It measures mechanical vibrations of the heart to assess cardiac function through seismocardiography technology.

The device is supplied by Seismed Instruments, Inc. and has FDA 510(k) clearance with the K892323 number. It is a Class II medical device regulated under product code DSB and regulation number 870.2770, with cardiovascular as its medical specialty.

Other devices from Seismed Instruments, Inc.

Questions

AI-generated answers, 27 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 Seismocardiograph SCG 1000 Series used for?

    The SCG 1000 Series is a plethysmograph and impedance device designed for cardiovascular applications. It measures mechanical vibrations of the heart to assess cardiac function through seismocardiography technology, providing valuable data for cardiovascular evaluation.

  • How is the SCG 1000 Series supplied and what is its regulatory status?

    The device is supplied by Seismed Instruments, Inc. and has FDA 510(k) clearance with the K892323 number. It is classified as a Class II medical device under product code DSB and regulation number 870.2770, with cardiovascular as its medical specialty.

  • Is the SCG 1000 Series a single-use or reusable device?

    The device data does not specify whether the SCG 1000 Series is designed for single-use or multiple uses. For specific information regarding device reusability, please consult the manufacturer's instructions for use or contact Seismed Instruments, Inc. directly.

  • What are the storage requirements for the SCG 1000 Series?

    The device data does not include specific storage requirements for the SCG 1000 Series. Proper storage conditions would typically be outlined in the manufacturer's instructions for use to maintain device integrity and functionality.