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FDA 510(k)

M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130

K-Number: K103214 · 2010-12-01

ApplicantLifeline Systems, Inc.
Decision Date2010-12-01
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 is the device name listed in this FDA 510(k) record. The listed applicant is Lifeline Systems, Inc.. It received FDA 510(k) clearance on 2010-12-01 under 510(k) number K103214. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130?

M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 is a medical device that received FDA 510(k) clearance on 2010-12-01. The listed applicant is Lifeline Systems, Inc.. The 510(k) number is K103214.

When did M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 receive FDA 510(k) clearance?

M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 received FDA 510(k) clearance on 2010-12-01, under 510(k) number K103214.

Who is the listed applicant for M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130?

The FDA 510(k) record lists Lifeline Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130?

The FDA product code for M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 is DRG.

Related Clinical Trials

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Other records listing Lifeline Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K914103LIFELINE(R) PERSONAL RESPONSE SYSTEMK834441BLOOD PRESSURE MONITOR BP600XK831638SINGLE BED ARRHYTHMIA MONITOR AM500

Related Devices (Code: DRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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