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FDA 510(k)

NORODYN 8000 SEMG SYSTEM, ND-8000

K-Number: K992439 · 1999-08-13

ApplicantMyotronics-Noromed, Inc.
Decision Date1999-08-13
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NORODYN 8000 SEMG SYSTEM, ND-8000 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 1999-08-13 under 510(k) number K992439. 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 NORODYN 8000 SEMG SYSTEM, ND-8000?

NORODYN 8000 SEMG SYSTEM, ND-8000 is a medical device that received FDA 510(k) clearance on 1999-08-13. The listed applicant is Myotronics-Noromed, Inc.. The 510(k) number is K992439.

When did NORODYN 8000 SEMG SYSTEM, ND-8000 receive FDA 510(k) clearance?

NORODYN 8000 SEMG SYSTEM, ND-8000 received FDA 510(k) clearance on 1999-08-13, under 510(k) number K992439.

Who is the listed applicant for NORODYN 8000 SEMG SYSTEM, ND-8000?

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 NORODYN 8000 SEMG SYSTEM, ND-8000?

The FDA product code for NORODYN 8000 SEMG SYSTEM, ND-8000 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-MONITORK013399MODEL MES-9000/EMG SYSTEMK003287MODEL K7 EVALUATION DEVICEK992694MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I

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Related Devices (Code: HCC)

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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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