FDA 510(k)

MODEL IC 3000

K-Number: K827292 · 1982-07-09

Decision Date1982-07-09

Product Code

DecisionSubstantially Equivalent

Device Summary

MODEL IC 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Xonics Medical Systems, Inc.. It received FDA 510(k) clearance on 1982-07-09 under 510(k) number K827292. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL IC 3000?

MODEL IC 3000 is a medical device that received FDA 510(k) clearance on 1982-07-09. The listed applicant is Xonics Medical Systems, Inc.. The 510(k) number is K827292.

When did MODEL IC 3000 receive FDA 510(k) clearance?

MODEL IC 3000 received FDA 510(k) clearance on 1982-07-09, under 510(k) number K827292.

Who is the listed applicant for MODEL IC 3000?

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

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 Xonics Medical Systems, Inc. as applicant

K820593ESP SERIES (X-RAY GENERATORS K791298DIAGNOSTIC ULTRASOUND SYSTEM K770693X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC

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.