Bo Med Bia

FDA 510(k) K811999 · Bomed Medical Mfr., Ltd.

Substantially Equivalent

510(k) numberK811999

Submission

Device name
Bo Med Bia
Applicant
Bomed Medical Mfr., Ltd.
Mchenry, IL, US
Received
July 11, 1981
Decision date
August 31, 1981
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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K223217Zynex Monitoring System, Model CM-1600DSB · Traditional Zynex Medical, Inc.06/16/2023SE
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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
K853706Bomed-CdmDSB · Traditional 04/14/1986SE
K853705Bomed-EeaDRX · Traditional 01/13/1986SE
K831422BioflowDSB · Traditional 09/12/1983SE
K831421Bomed BioconDSB · Traditional 09/12/1983SE
K830792Pulsette 110 Transcutaneous Elec-NerveGZJ · Traditional 03/29/1983SE
K813020Bomed-NccomDXG · Traditional 12/14/1981SE
K810064Pulsarii, High Volt. Galvanic Musc. StimIPF · Traditional 01/26/1981SE

Questions and answers

When was Bo Med Bia cleared by the FDA?

Bo Med Bia (K811999) received a 510(k) decision of Substantially Equivalent on August 31, 1981, 51 days after the submission was received.

What is the product code of K811999?

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