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FDA 510(k)

ACCUSONIC A-SCAN MODEL, 24-4000

K-Number: K032956 · 2003-10-10

Decision Date2003-10-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCUSONIC A-SCAN MODEL, 24-4000 is the device name listed in this FDA 510(k) record. The listed applicant is Accutome, Inc.. It received FDA 510(k) clearance on 2003-10-10 under 510(k) number K032956. 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 ACCUSONIC A-SCAN MODEL, 24-4000?

ACCUSONIC A-SCAN MODEL, 24-4000 is a medical device that received FDA 510(k) clearance on 2003-10-10. The listed applicant is Accutome, Inc.. The 510(k) number is K032956.

When did ACCUSONIC A-SCAN MODEL, 24-4000 receive FDA 510(k) clearance?

ACCUSONIC A-SCAN MODEL, 24-4000 received FDA 510(k) clearance on 2003-10-10, under 510(k) number K032956.

Who is the listed applicant for ACCUSONIC A-SCAN MODEL, 24-4000?

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

What is the FDA product code for ACCUSONIC A-SCAN MODEL, 24-4000?

The FDA product code for ACCUSONIC A-SCAN MODEL, 24-4000 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.

Other records listing Accutome, 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.

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.

Official Source

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