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FDA 510(k)

ACCUPEN

K-Number: K083377 · 2009-07-27

ApplicantAccutome Ultrasound, Inc.
Decision Date2009-07-27
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ACCUPEN is the device name listed in this FDA 510(k) record. The listed applicant is Accutome Ultrasound, Inc.. It received FDA 510(k) clearance on 2009-07-27 under 510(k) number K083377. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUPEN?

ACCUPEN is a medical device that received FDA 510(k) clearance on 2009-07-27. The listed applicant is Accutome Ultrasound, Inc.. The 510(k) number is K083377.

When did ACCUPEN receive FDA 510(k) clearance?

ACCUPEN received FDA 510(k) clearance on 2009-07-27, under 510(k) number K083377.

Who is the listed applicant for ACCUPEN?

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

What is the FDA product code for ACCUPEN?

The FDA product code for ACCUPEN is HKX.

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.

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Other records listing Accutome Ultrasound, 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.

K070943B-SCAN PLUSK042752ACCUPACH V

Related Devices (Code: HKX)

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

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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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