Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1

K-Number: K994203 · 2000-03-06

Decision Date2000-03-06
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 is the device name listed in this FDA 510(k) record. The listed applicant is Bonart Co., Ltd.. It received FDA 510(k) clearance on 2000-03-06 under 510(k) number K994203. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1?

ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 is a medical device that received FDA 510(k) clearance on 2000-03-06. The listed applicant is Bonart Co., Ltd.. The 510(k) number is K994203.

When did ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 receive FDA 510(k) clearance?

ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 received FDA 510(k) clearance on 2000-03-06, under 510(k) number K994203.

Who is the listed applicant for ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1?

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

What is the FDA product code for ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1?

The FDA product code for ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 is ELC.

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.

Other records listing Bonart Co., Ltd. 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.

View all 14 devices →

Related Devices (Code: ELC)

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.

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.

↑