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FDA 510(k)

LIFESYNE SYSTEMS

K-Number: K030795 · 2003-08-05

ApplicantGmp/Companies, Inc.
Decision Date2003-08-05
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFESYNE SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Gmp/Companies, Inc.. It received FDA 510(k) clearance on 2003-08-05 under 510(k) number K030795. 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 LIFESYNE SYSTEMS?

LIFESYNE SYSTEMS is a medical device that received FDA 510(k) clearance on 2003-08-05. The listed applicant is Gmp/Companies, Inc.. The 510(k) number is K030795.

When did LIFESYNE SYSTEMS receive FDA 510(k) clearance?

LIFESYNE SYSTEMS received FDA 510(k) clearance on 2003-08-05, under 510(k) number K030795.

Who is the listed applicant for LIFESYNE SYSTEMS?

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

What is the FDA product code for LIFESYNE SYSTEMS?

The FDA product code for LIFESYNE SYSTEMS is DRG.

Related Clinical Trials

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.

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Other records listing Gmp/Companies, 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.

K050027LAPAROCISION SCOPE CONTROLLER SYSTEM

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

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

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