Physioflow Enduro

FDA 510(k) K103283 · Vasocom, Inc.

Substantially Equivalent

510(k) numberK103283

Submission

Device name
Physioflow Enduro
Applicant
Vasocom, Inc.
Bristol, PA, US
Received
November 5, 2010
Decision date
December 3, 2010
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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Questions and answers

When was Physioflow Enduro cleared by the FDA?

Physioflow Enduro (K103283) received a 510(k) decision of Substantially Equivalent on December 3, 2010, 28 days after the submission was received.

What is the product code of K103283?

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