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FDA 510(k)

MOBILE SOPHIE MODIFICATION

K-Number: K934373 · 1994-04-07

ApplicantPlanmed OY
Decision Date1994-04-07
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOBILE SOPHIE MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Planmed OY. It received FDA 510(k) clearance on 1994-04-07 under 510(k) number K934373. 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 MOBILE SOPHIE MODIFICATION?

MOBILE SOPHIE MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-04-07. The listed applicant is Planmed OY. The 510(k) number is K934373.

When did MOBILE SOPHIE MODIFICATION receive FDA 510(k) clearance?

MOBILE SOPHIE MODIFICATION received FDA 510(k) clearance on 1994-04-07, under 510(k) number K934373.

Who is the listed applicant for MOBILE SOPHIE MODIFICATION?

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 MOBILE SOPHIE MODIFICATION?

The FDA product code for MOBILE SOPHIE MODIFICATION 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.

K250318Planmed XFIK211720Planmed Clarity 2D, Planmed Clarify SK213278Planmed VerityK192317Planmed Clarity 2D and Clarity SK180918Planmed VerityK163328Planmed Clarity

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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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, Inc.

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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