Omega 5000

FDA 510(k) K833978 · Invivo Research Labs, Inc.

Substantially Equivalent

510(k) numberK833978

Submission

Device name
Omega 5000
Applicant
Invivo Research Labs, Inc.
Mchenry, IL, US
Received
November 17, 1983
Decision date
March 9, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXN – System, Measurement, Blood-Pressure, Non-Invasive
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1130
Specialty
Cardiovascular

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K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional Joytech Healthcare Co. , Ltd.08/13/2026SE
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K253126Wrist Blood Pressure Monitor (XW-05)DXN · Traditional Shenzhen Ziqing Medical Equipment Co., Ltd.06/18/2026SE
K260693VicorderCS (VCS-SYS-1100)DXN · Traditional 80 Beats Medical GmbH06/16/2026SE

More from 80 Beats Medical GmbH

510(k)DeviceDecision
K864730Invivo Pulse Oximeter, Model 4500DQA · Traditional 05/06/1987SE
K864889Omni-TrakDSB · Traditional 03/06/1987SE
K810838Neonatal Blood Pressure CuffDXQ · Traditional 04/03/1981SE
K800066NiastatDXN · Traditional 02/29/1980SE

Questions and answers

When was Omega 5000 cleared by the FDA?

Omega 5000 (K833978) received a 510(k) decision of Substantially Equivalent on March 9, 1984, 113 days after the submission was received.

What is the product code of K833978?

The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.