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FDA 510(k)

PLANMED SOPHIE

K-Number: K904953 · 1991-04-18

ApplicantPlanmeca USA, Inc.
Decision Date1991-04-18
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PLANMED SOPHIE is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca USA, Inc.. It received FDA 510(k) clearance on 1991-04-18 under 510(k) number K904953. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLANMED SOPHIE?

PLANMED SOPHIE is a medical device that received FDA 510(k) clearance on 1991-04-18. The listed applicant is Planmeca USA, Inc.. The 510(k) number is K904953.

When did PLANMED SOPHIE receive FDA 510(k) clearance?

PLANMED SOPHIE received FDA 510(k) clearance on 1991-04-18, under 510(k) number K904953.

Who is the listed applicant for PLANMED SOPHIE?

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

What is the FDA product code for PLANMED SOPHIE?

The FDA product code for PLANMED SOPHIE is IZH.

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Other records listing Planmeca USA, 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.

K111361PLANMED NUANCE EXCELK081699PLANMECA SOVEREIGNK923534PM2002 PROLINEK923533ADMARKK923462DELIGHTK923461PM2002 PROLINE, PM2002 PROLINE EC

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Related Devices (Code: IZH)

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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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