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FDA 510(k)

ACCENT

K-Number: K013574 · 2002-01-15

ApplicantConfirma, Inc.
Decision Date2002-01-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCENT is the device name listed in this FDA 510(k) record. The listed applicant is Confirma, Inc.. It received FDA 510(k) clearance on 2002-01-15 under 510(k) number K013574. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCENT?

ACCENT is a medical device that received FDA 510(k) clearance on 2002-01-15. The listed applicant is Confirma, Inc.. The 510(k) number is K013574.

When did ACCENT receive FDA 510(k) clearance?

ACCENT received FDA 510(k) clearance on 2002-01-15, under 510(k) number K013574.

Who is the listed applicant for ACCENT?

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

What is the FDA product code for ACCENT?

The FDA product code for ACCENT is LLZ.

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Other records listing Confirma, 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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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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