Physioflow System

FDA 510(k) K060387 · Vasocom, Inc.

Substantially Equivalent

510(k) numberK060387

Submission

Device name
Physioflow System
Applicant
Vasocom, Inc.
Bristol, PA, US
Received
February 14, 2006
Decision date
April 10, 2008
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.

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Questions and answers

When was Physioflow System cleared by the FDA?

Physioflow System (K060387) received a 510(k) decision of Substantially Equivalent on April 10, 2008, 786 days after the submission was received.

What is the product code of K060387?

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