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FDA 510(k)

ACCUPACH V

K-Number: K042752 · 2004-11-10

ApplicantAccutome Ultrasound, Inc.
Decision Date2004-11-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCUPACH V 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 2004-11-10 under 510(k) number K042752. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUPACH V?

ACCUPACH V is a medical device that received FDA 510(k) clearance on 2004-11-10. The listed applicant is Accutome Ultrasound, Inc.. The 510(k) number is K042752.

When did ACCUPACH V receive FDA 510(k) clearance?

ACCUPACH V received FDA 510(k) clearance on 2004-11-10, under 510(k) number K042752.

Who is the listed applicant for ACCUPACH V?

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 ACCUPACH V?

The FDA product code for ACCUPACH V is IYO.

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.

K083377ACCUPENK070943B-SCAN PLUS

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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