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)

MYO-TRODE SG DISPOSABLE ELECTRODE

K-Number: K040400 · 2004-07-20

ApplicantMyotronics-Noromed, Inc.
Decision Date2004-07-20
Product CodeNUW
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MYO-TRODE SG DISPOSABLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Myotronics-Noromed, Inc.. It received FDA 510(k) clearance on 2004-07-20 under 510(k) number K040400. The device is classified under product code NUW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYO-TRODE SG DISPOSABLE ELECTRODE?

MYO-TRODE SG DISPOSABLE ELECTRODE is a medical device that received FDA 510(k) clearance on 2004-07-20. The listed applicant is Myotronics-Noromed, Inc.. The 510(k) number is K040400.

When did MYO-TRODE SG DISPOSABLE ELECTRODE receive FDA 510(k) clearance?

MYO-TRODE SG DISPOSABLE ELECTRODE received FDA 510(k) clearance on 2004-07-20, under 510(k) number K040400.

Who is the listed applicant for MYO-TRODE SG DISPOSABLE ELECTRODE?

The FDA 510(k) record lists Myotronics-Noromed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYO-TRODE SG DISPOSABLE ELECTRODE?

The FDA product code for MYO-TRODE SG DISPOSABLE ELECTRODE is NUW.

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 Myotronics-Noromed, Inc. 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.

K111687EMG SYSTEMK031998MODEL J-5 MVO-MONITORK013399MODEL MES-9000/EMG SYSTEMK003287MODEL K7 EVALUATION DEVICEK992694MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-IK992439NORODYN 8000 SEMG SYSTEM, ND-8000

View all 7 devices →

Related Devices (Code: NUW)

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.

K243290BTL-785MJBTL Industries, Inc.K203525D functionIto Co., Ltd.K031998MODEL J-5 MVO-MONITORMyotronics-Noromed, Inc.K901902ACUSOURCE 600 FOR USE WITH TMJ ELECTRODEMicrocurrent Research, Inc.K890143ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CONMicrocurrent Research, Inc.K842224BNS 40Myo-Tronics Research, 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.

↑