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)

RIONET HM-02

K-Number: K943808 · 1995-05-24

ApplicantRockwin Corp.
Decision Date1995-05-24
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RIONET HM-02 is the device name listed in this FDA 510(k) record. The listed applicant is Rockwin Corp.. It received FDA 510(k) clearance on 1995-05-24 under 510(k) number K943808. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIONET HM-02?

RIONET HM-02 is a medical device that received FDA 510(k) clearance on 1995-05-24. The listed applicant is Rockwin Corp.. The 510(k) number is K943808.

When did RIONET HM-02 receive FDA 510(k) clearance?

RIONET HM-02 received FDA 510(k) clearance on 1995-05-24, under 510(k) number K943808.

Who is the listed applicant for RIONET HM-02?

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

What is the FDA product code for RIONET HM-02?

The FDA product code for RIONET HM-02 is ESD.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Rockwin Corp. 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.

K974129HI-69E, HI-69N, HI-69PK935559HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000

Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, 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.

↑