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)

RDH-2000

K-Number: K023213 · 2003-01-16

ApplicantAnodia Systems
Decision Date2003-01-16
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RDH-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Anodia Systems. It received FDA 510(k) clearance on 2003-01-16 under 510(k) number K023213. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RDH-2000?

RDH-2000 is a medical device that received FDA 510(k) clearance on 2003-01-16. The listed applicant is Anodia Systems. The 510(k) number is K023213.

When did RDH-2000 receive FDA 510(k) clearance?

RDH-2000 received FDA 510(k) clearance on 2003-01-16, under 510(k) number K023213.

Who is the listed applicant for RDH-2000?

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

What is the FDA product code for RDH-2000?

The FDA product code for RDH-2000 is EIA.

Other records listing Anodia Systems 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.

K023896C-1890K023815C-1805MK925378STERI-SOL SOLUTION, MODIFICATION

Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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.

↑