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FDA 510(k)

Planmed Verity

K-Number: K213278 · 2022-04-28

ApplicantPlanmed OY
Decision Date2022-04-28
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Planmed Verity is the device name listed in this FDA 510(k) record. The listed applicant is Planmed OY. It received FDA 510(k) clearance on 2022-04-28 under 510(k) number K213278. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Planmed Verity?

Planmed Verity is a medical device that received FDA 510(k) clearance on 2022-04-28. The listed applicant is Planmed OY. The 510(k) number is K213278.

When did Planmed Verity receive FDA 510(k) clearance?

Planmed Verity received FDA 510(k) clearance on 2022-04-28, under 510(k) number K213278.

Who is the listed applicant for Planmed Verity?

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 Verity?

The FDA product code for Planmed Verity is OAS.

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 SK192317Planmed Clarity 2D and Clarity SK180918Planmed VerityK163328Planmed Clarity

Related Devices (Code: OAS)

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.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

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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