Zoefluid Status Monitor (Model Zoe 2B)

FDA 510(k) K112830 · Noninvasive Medical Technologies, Inc.

Substantially Equivalent

510(k) numberK112830

Submission

Device name
Zoefluid Status Monitor (Model Zoe 2B)
Applicant
Noninvasive Medical Technologies, Inc.
Las Vegas, NV, US
Received
September 28, 2011
Decision date
November 13, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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.

510(k)DeviceDecision
K133301Zoe Fluid Status MonitorDSB · Special 01/22/2014SE
K131509Zoe Fluid Status MonitorDSB · Special 06/28/2013SE
K042113Zoe Fluid Status MonitorDSB · Special 09/14/2004SE

Questions and answers

When was Zoefluid Status Monitor (Model Zoe 2B) cleared by the FDA?

Zoefluid Status Monitor (Model Zoe 2B) (K112830) received a 510(k) decision of Substantially Equivalent on November 13, 2012, 412 days after the submission was received.

What is the product code of K112830?

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