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FDA 510(k)

SURETONE

K-Number: K011588 · 2002-03-28

ApplicantSuretone International
Decision Date2002-03-28
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SURETONE is the device name listed in this FDA 510(k) record. The listed applicant is Suretone International. It received FDA 510(k) clearance on 2002-03-28 under 510(k) number K011588. 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 SURETONE?

SURETONE is a medical device that received FDA 510(k) clearance on 2002-03-28. The listed applicant is Suretone International. The 510(k) number is K011588.

When did SURETONE receive FDA 510(k) clearance?

SURETONE received FDA 510(k) clearance on 2002-03-28, under 510(k) number K011588.

Who is the listed applicant for SURETONE?

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

What is the FDA product code for SURETONE?

The FDA product code for SURETONE is IPF.

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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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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