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FDA 510(k)

ARIA

K-Number: K001317 · 2000-07-21

ApplicantDel Mar Medical Systems, LLC
Decision Date2000-07-21
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARIA is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Medical Systems, LLC. It received FDA 510(k) clearance on 2000-07-21 under 510(k) number K001317. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIA?

ARIA is a medical device that received FDA 510(k) clearance on 2000-07-21. The listed applicant is Del Mar Medical Systems, LLC. The 510(k) number is K001317.

When did ARIA receive FDA 510(k) clearance?

ARIA received FDA 510(k) clearance on 2000-07-21, under 510(k) number K001317.

Who is the listed applicant for ARIA?

The FDA 510(k) record lists Del Mar Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARIA?

The FDA product code for ARIA is MWJ.

Related PubMed Literature

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.

PMID: 42566800Safety, feasibility, and outcomes of deep brain stimulation in young children excluded from the FDA Humanitarian Device Exemption: analysis of the CHILD-DBS registry.Journal of neurosurgery. Pediatrics ()PMID: 39516116Understanding Variation Among Medical Device Reporting Sources: A Study of the MAUDE Database.Clinical therapeutics ()

Other records listing Del Mar Medical Systems, LLC 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.

K993620IMPRESARIO

Related Devices (Code: MWJ)

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.

K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)Shenzhen Xinyan Medical Technology Co.,ltd.K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.K253562medilogFDSchiller AGK253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K231424HeartBeam AIMIGo(TM) SystemHeartbeam, 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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