Zoe Fluid Status Monitor

FDA 510(k) K133301 · Noninvasive Medical Technologies, Inc.

Substantially Equivalent

510(k) numberK133301

Submission

Device name
Zoe Fluid Status Monitor
Applicant
Noninvasive Medical Technologies, Inc.
Las Vegas, NV, US
Received
October 25, 2013
Decision date
January 22, 2014
Decision
Substantially Equivalent (SESE)
Type
Special 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
K131509Zoe Fluid Status MonitorDSB · Special 06/28/2013SE
K112830Zoefluid Status Monitor (Model Zoe 2B)DSB · Traditional 11/13/2012SE
K042113Zoe Fluid Status MonitorDSB · Special 09/14/2004SE

Questions and answers

When was Zoe Fluid Status Monitor cleared by the FDA?

Zoe Fluid Status Monitor (K133301) received a 510(k) decision of Substantially Equivalent on January 22, 2014, 89 days after the submission was received.

What is the product code of K133301?

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