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510(k) K181165

Philips wearable biosensor-G5 Solution by Connected Sensing- A Division of Philips Medical Systems — Product Code DRT

K181165 is an FDA 510(k) premarket notification submitted by Connected Sensing- A Division of Philips Medical Systems for the device "Philips wearable biosensor-G5 Solution". The FDA issued a decision of Substantially Equivalent on March 7, 2019. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2019
Date Received
May 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

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FDA data resources