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FDA 510(k)

K6-I DIAGNOSTIC SYSTEM

K-Number: K922456 · 1994-06-09

ApplicantMyo-Tronics, Inc.
Decision Date1994-06-09
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

K6-I DIAGNOSTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Myo-Tronics, Inc.. It received FDA 510(k) clearance on 1994-06-09 under 510(k) number K922456. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the K6-I DIAGNOSTIC SYSTEM?

K6-I DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1994-06-09. The listed applicant is Myo-Tronics, Inc.. The 510(k) number is K922456.

When did K6-I DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

K6-I DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1994-06-09, under 510(k) number K922456.

Who is the listed applicant for K6-I DIAGNOSTIC SYSTEM?

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

What is the FDA product code for K6-I DIAGNOSTIC SYSTEM?

The FDA product code for K6-I DIAGNOSTIC SYSTEM 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.

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Other records listing Myo-Tronics, 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.

K970116ESG-1 ELECTROSONOGRAM (ESG-1)K944134K6-1 DIAGNOSTIC SYSTEM VERSION 3.1K922270PHYSIOTECH 4000 OR NORODYN 8000K921919MS-100 MYO-SCANNER OR MS-100 EMG SCANNERK905449ELECTROSONOGRAM ESG-1

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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