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)

MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I

K-Number: K992694 · 1999-09-10

ApplicantMyotronics-Noromed, Inc.
Decision Date1999-09-10
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I 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 1999-09-10 under 510(k) number K992694. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I?

MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I is a medical device that received FDA 510(k) clearance on 1999-09-10. The listed applicant is Myotronics-Noromed, Inc.. The 510(k) number is K992694.

When did MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I receive FDA 510(k) clearance?

MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I received FDA 510(k) clearance on 1999-09-10, under 510(k) number K992694.

Who is the listed applicant for MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I?

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 MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I?

The FDA product code for MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I is KZM.

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 SYSTEMK040400MYO-TRODE SG DISPOSABLE ELECTRODEK031998MODEL J-5 MVO-MONITORK013399MODEL MES-9000/EMG SYSTEMK003287MODEL K7 EVALUATION DEVICEK992439NORODYN 8000 SEMG SYSTEM, ND-8000

View all 7 devices →

Related Devices (Code: KZM)

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.

K161716TEETHAN 2.0Bts S.P.A.K130158M-SCANBio-Research Associates, Inc.K113677GRINDCARE MEASUREMedotech A/SK082927BIOEMG IIIBio-Research Associates, Inc.K043373DOLOTENS DENTAL TM 1Neuromuscular Technologies, Inc.K030869BITESTRIPS.L.P. , Ltd.

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.

↑