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FDA 510(k)

CHAMPION

K-Number: K950815 · 1995-05-12

ApplicantKleinfeld, Kaplan and Becker
Decision Date1995-05-12
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CHAMPION is the device name listed in this FDA 510(k) record. The listed applicant is Kleinfeld, Kaplan and Becker. It received FDA 510(k) clearance on 1995-05-12 under 510(k) number K950815. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHAMPION?

CHAMPION is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Kleinfeld, Kaplan and Becker. The 510(k) number is K950815.

When did CHAMPION receive FDA 510(k) clearance?

CHAMPION received FDA 510(k) clearance on 1995-05-12, under 510(k) number K950815.

Who is the listed applicant for CHAMPION?

The FDA 510(k) record lists Kleinfeld, Kaplan and Becker as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHAMPION?

The FDA product code for CHAMPION is IOR.

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Other records listing Kleinfeld, Kaplan and Becker 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.

K945957AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER

Related Devices (Code: IOR)

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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