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FDA 510(k)

AMIGO RT

K-Number: K981121 · 1998-06-30

Decision Date1998-06-30
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AMIGO RT is the device name listed in this FDA 510(k) record. The listed applicant is Amigo Mobility Intl., Inc.. It received FDA 510(k) clearance on 1998-06-30 under 510(k) number K981121. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIGO RT?

AMIGO RT is a medical device that received FDA 510(k) clearance on 1998-06-30. The listed applicant is Amigo Mobility Intl., Inc.. The 510(k) number is K981121.

When did AMIGO RT receive FDA 510(k) clearance?

AMIGO RT received FDA 510(k) clearance on 1998-06-30, under 510(k) number K981121.

Who is the listed applicant for AMIGO RT?

The FDA 510(k) record lists Amigo Mobility Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMIGO RT?

The FDA product code for AMIGO RT is INI.

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.

Other records listing Amigo Mobility Intl., 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.

View all 8 devices →

Related Devices (Code: INI)

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.

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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