Modified Seismocardiograph

FDA 510(k) K900130 · Seismed Instruments, Inc.

Substantially Equivalent

510(k) numberK900130

Submission

Device name
Modified Seismocardiograph
Applicant
Seismed Instruments, Inc.
Minneapolis, MN, US
Received
January 5, 1990
Decision date
March 28, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DSB – Plethysmograph, Impedance
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

Other 510(k)s with product code DSB

510(k)DeviceApplicantDecision
K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional ImpediMed Limited08/17/2026SE
K250634BCM2-Body Composition MonitorDSB · Traditional Fresenius Medical Care Renal Therapies Group, LLC11/24/2025SE
K243727Re:BalansDSB · Traditional Mode Sensors AS10/16/2025SE
K250922Edema Guard Monitor (EGM) CardioSet-001DSB · Traditional Cardioset Medical , Ltd.09/09/2025SE
K232089SOZO ProDSB · Traditional ImpediMed Limited10/17/2023SE
K223217Zynex Monitoring System, Model CM-1600DSB · Traditional Zynex Medical, Inc.06/16/2023SE
K211585Bodyport Cardiac ScaleDSB · Traditional Bodyport, Inc.07/29/2022SE
K203473SozoDSB · Traditional ImpediMed Limited04/19/2021SE
K193410SOZO Body Fluid AnalyzerDSB · Traditional ImpediMed Limited10/02/2020SE
K191697Cardiac Monitor 1500DSB · Traditional Zynex Medical, Inc.02/21/2020SE

More from Zynex Medical, Inc.

510(k)DeviceDecision
K910994Modified SeismocardiographDSB · Traditional 01/15/1992SE
K892323Seismocardiograph - Scg(Tm) 1000 SeriesDSB · Traditional 10/30/1989SE

Questions and answers

When was Modified Seismocardiograph cleared by the FDA?

Modified Seismocardiograph (K900130) received a 510(k) decision of Substantially Equivalent on March 28, 1990, 82 days after the submission was received.

What is the product code of K900130?

The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.