ReDs Wearable System

FDA 510(k) K150095 · Sensible Medical Innovations , Ltd.

Substantially Equivalent

510(k) numberK150095

Submission

Device name
ReDs Wearable System
Applicant
Sensible Medical Innovations , Ltd.
Netanya, IL
Received
January 16, 2015
Decision date
August 6, 2015
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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Questions and answers

When was ReDs Wearable System cleared by the FDA?

ReDs Wearable System (K150095) received a 510(k) decision of Substantially Equivalent on August 6, 2015, 202 days after the submission was received.

What is the product code of K150095?

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