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FDA 510(k)

MODEL MES-9000/EMG SYSTEM

K-Number: K013399 · 2001-11-13

ApplicantMyotronics-Noromed, Inc.
Decision Date2001-11-13
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL MES-9000/EMG SYSTEM 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 2001-11-13 under 510(k) number K013399. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL MES-9000/EMG SYSTEM?

MODEL MES-9000/EMG SYSTEM is a medical device that received FDA 510(k) clearance on 2001-11-13. The listed applicant is Myotronics-Noromed, Inc.. The 510(k) number is K013399.

When did MODEL MES-9000/EMG SYSTEM receive FDA 510(k) clearance?

MODEL MES-9000/EMG SYSTEM received FDA 510(k) clearance on 2001-11-13, under 510(k) number K013399.

Who is the listed applicant for MODEL MES-9000/EMG SYSTEM?

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 MES-9000/EMG SYSTEM?

The FDA product code for MODEL MES-9000/EMG SYSTEM is HCC.

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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-MONITORK003287MODEL K7 EVALUATION DEVICEK992694MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-IK992439NORODYN 8000 SEMG SYSTEM, ND-8000

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Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

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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