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FDA 510(k)

AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL

K-Number: K881196 · 1989-06-16

ApplicantBiometer Intl. A/S
Decision Date1989-06-16
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL is the device name listed in this FDA 510(k) record. The listed applicant is Biometer Intl. A/S. It received FDA 510(k) clearance on 1989-06-16 under 510(k) number K881196. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL?

AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Biometer Intl. A/S. The 510(k) number is K881196.

When did AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL receive FDA 510(k) clearance?

AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL received FDA 510(k) clearance on 1989-06-16, under 510(k) number K881196.

Who is the listed applicant for AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL?

The FDA 510(k) record lists Biometer Intl. A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL?

The FDA product code for AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL is IPF.

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Other records listing Biometer Intl. A/S as applicant

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Related Devices (Code: IPF)

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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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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