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FDA 510(k)

MODEL K7 EVALUATION DEVICE

K-Number: K003287 · 2000-11-06

ApplicantMyotronics-Noromed, Inc.
Decision Date2000-11-06
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL K7 EVALUATION DEVICE 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 2000-11-06 under 510(k) number K003287. 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 MODEL K7 EVALUATION DEVICE?

MODEL K7 EVALUATION DEVICE is a medical device that received FDA 510(k) clearance on 2000-11-06. The listed applicant is Myotronics-Noromed, Inc.. The 510(k) number is K003287.

When did MODEL K7 EVALUATION DEVICE receive FDA 510(k) clearance?

MODEL K7 EVALUATION DEVICE received FDA 510(k) clearance on 2000-11-06, under 510(k) number K003287.

Who is the listed applicant for MODEL K7 EVALUATION DEVICE?

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 MODEL K7 EVALUATION DEVICE?

The FDA product code for MODEL K7 EVALUATION DEVICE is KZM.

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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 SYSTEMK992694MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-IK992439NORODYN 8000 SEMG SYSTEM, ND-8000

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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.

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