Cleared Traditional

K181165 - Philips wearable biosensor-G5 Solution (FDA 510(k) Clearance)

K181165 · Connected Sensing- A Division of Philips Medical Systems · Cardiovascular device

Mar 2019

Decision

309d

Days

Class 2

Risk

K181165 is an FDA 510(k) clearance for the Philips wearable biosensor-G5 Solution. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II - Special Controls, product code DRT).

Submitted by Connected Sensing- A Division of Philips Medical Systems (Cambridge, US). The FDA issued a Cleared decision on March 7, 2019, 309 days after receiving the submission on May 2, 2018.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K181165 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 02, 2018
Decision Date	March 07, 2019
Days to Decision	309 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF