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FDA 510(k)

PLANMED SOPHIE AND SOPHIE CLASSIC

K-Number: K991826 · 1999-08-10

ApplicantPlanmed OY
Decision Date1999-08-10
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PLANMED SOPHIE AND SOPHIE CLASSIC is the device name listed in this FDA 510(k) record. The listed applicant is Planmed OY. It received FDA 510(k) clearance on 1999-08-10 under 510(k) number K991826. 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 AND SOPHIE CLASSIC?

PLANMED SOPHIE AND SOPHIE CLASSIC is a medical device that received FDA 510(k) clearance on 1999-08-10. The listed applicant is Planmed OY. The 510(k) number is K991826.

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

PLANMED SOPHIE AND SOPHIE CLASSIC received FDA 510(k) clearance on 1999-08-10, under 510(k) number K991826.

Who is the listed applicant for PLANMED SOPHIE AND SOPHIE CLASSIC?

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

What is the FDA product code for PLANMED SOPHIE AND SOPHIE CLASSIC?

The FDA product code for PLANMED SOPHIE AND SOPHIE CLASSIC is IZH.

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Other records listing Planmed OY 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.

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Related Devices (Code: IZH)

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

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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