Omni-Trak

FDA 510(k) K864889 · Invivo Research Labs, Inc.

Substantially Equivalent

510(k) numberK864889

Submission

Device name
Omni-Trak
Applicant
Invivo Research Labs, Inc.
Tulsa, OK, US
Received
December 12, 1986
Decision date
March 6, 1987
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

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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
K864730Invivo Pulse Oximeter, Model 4500DQA · Traditional 05/06/1987SE
K833978Omega 5000DXN · Traditional 03/09/1984SE
K810838Neonatal Blood Pressure CuffDXQ · Traditional 04/03/1981SE
K800066NiastatDXN · Traditional 02/29/1980SE

Questions and answers

When was Omni-Trak cleared by the FDA?

Omni-Trak (K864889) received a 510(k) decision of Substantially Equivalent on March 6, 1987, 84 days after the submission was received.

What is the product code of K864889?

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