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FDA 510(k)

TONE-A-MATIC

K-Number: K130052 · 2013-12-20

ApplicantTone-A-Matic International, Inc.
Decision Date2013-12-20
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TONE-A-MATIC is the device name listed in this FDA 510(k) record. The listed applicant is Tone-A-Matic International, Inc.. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K130052. 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 TONE-A-MATIC?

TONE-A-MATIC is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Tone-A-Matic International, Inc.. The 510(k) number is K130052.

When did TONE-A-MATIC receive FDA 510(k) clearance?

TONE-A-MATIC received FDA 510(k) clearance on 2013-12-20, under 510(k) number K130052.

Who is the listed applicant for TONE-A-MATIC?

The FDA 510(k) record lists Tone-A-Matic International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TONE-A-MATIC?

The FDA product code for TONE-A-MATIC is IPF.

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Other records listing Tone-A-Matic International, 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: IPF)

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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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