Physioflow Q-Link

FDA 510(k) K140102 · Vasocom, Inc.

Substantially Equivalent

510(k) numberK140102

Submission

Device name
Physioflow Q-Link
Applicant
Vasocom, Inc.
Bristol, PA, US
Received
January 15, 2014
Decision date
February 12, 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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Questions and answers

When was Physioflow Q-Link cleared by the FDA?

Physioflow Q-Link (K140102) received a 510(k) decision of Substantially Equivalent on February 12, 2014, 28 days after the submission was received.

What is the product code of K140102?

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