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FDA 510(k)

S HEALTH

K-Number: K132148 · 2013-12-04

ApplicantSamsung Electronics Co., Ltd.
Decision Date2013-12-04
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

S HEALTH is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2013-12-04 under 510(k) number K132148. 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 S HEALTH?

S HEALTH is a medical device that received FDA 510(k) clearance on 2013-12-04. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K132148.

When did S HEALTH receive FDA 510(k) clearance?

S HEALTH received FDA 510(k) clearance on 2013-12-04, under 510(k) number K132148.

Who is the listed applicant for S HEALTH?

The FDA 510(k) record lists Samsung Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S HEALTH?

The FDA product code for S HEALTH is DRG.

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Related PubMed Literature

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PMID: 40416675Generative AI's healthcare professional role creep: a cross-sectional evaluation of publicly accessible, customised health-related GPTs.Frontiers in public health ()

Other records listing Samsung Electronics Co., Ltd. as applicant

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K260481GC85AK261187Hearing Aid FeatureK261011Sleep Apnea Feature (v2.0)K242651GM85K242478GF85 (models GF85-3P, GF85-SP)K240909Samsung ECG App v 1.3 (ECG)

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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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