Sorba Steorra Non-Invasive Impedance Cardiograph

FDA 510(k) K014299 · Sorba Medical Systems, Inc.

Substantially Equivalent

510(k) numberK014299

Submission

Device name
Sorba Steorra Non-Invasive Impedance Cardiograph
Applicant
Sorba Medical Systems, Inc.
Brookfield, WI, US
Received
December 31, 2001
Decision date
January 30, 2002
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

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

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More from Zynex Medical, Inc.

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K950389Sorba Model CIC-1000 Non-Invasive Hemodynamic MonitorDSB · Traditional 08/15/1995SE
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K895017Sorba Model CIC-1000, Comp. Impedance CardiographDXG · Traditional 03/14/1990SE

Questions and answers

When was Sorba Steorra Non-Invasive Impedance Cardiograph cleared by the FDA?

Sorba Steorra Non-Invasive Impedance Cardiograph (K014299) received a 510(k) decision of Substantially Equivalent on January 30, 2002, 30 days after the submission was received.

What is the product code of K014299?

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