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FDA 510(k)

COMPANION MODEL 221, 321, 421

K-Number: K012258 · 2001-12-03

ApplicantGolden Technologies, Inc.
Decision Date2001-12-03
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMPANION MODEL 221, 321, 421 is the device name listed in this FDA 510(k) record. The listed applicant is Golden Technologies, Inc.. It received FDA 510(k) clearance on 2001-12-03 under 510(k) number K012258. 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 COMPANION MODEL 221, 321, 421?

COMPANION MODEL 221, 321, 421 is a medical device that received FDA 510(k) clearance on 2001-12-03. The listed applicant is Golden Technologies, Inc.. The 510(k) number is K012258.

When did COMPANION MODEL 221, 321, 421 receive FDA 510(k) clearance?

COMPANION MODEL 221, 321, 421 received FDA 510(k) clearance on 2001-12-03, under 510(k) number K012258.

Who is the listed applicant for COMPANION MODEL 221, 321, 421?

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

What is the FDA product code for COMPANION MODEL 221, 321, 421?

The FDA product code for COMPANION MODEL 221, 321, 421 is INI.

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Other records listing Golden Technologies, 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.

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Related Devices (Code: INI)

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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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