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FDA 510(k)

Comfort Marker 2.0

K-Number: K222112 · 2023-03-30

ApplicantMedical Precision BV
Decision Date2023-03-30
Product CodeQRN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Comfort Marker 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Precision BV. It received FDA 510(k) clearance on 2023-03-30 under 510(k) number K222112. The device is classified under product code QRN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Comfort Marker 2.0?

Comfort Marker 2.0 is a medical device that received FDA 510(k) clearance on 2023-03-30. The listed applicant is Medical Precision BV. The 510(k) number is K222112.

When did Comfort Marker 2.0 receive FDA 510(k) clearance?

Comfort Marker 2.0 received FDA 510(k) clearance on 2023-03-30, under 510(k) number K222112.

Who is the listed applicant for Comfort Marker 2.0?

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

What is the FDA product code for Comfort Marker 2.0?

The FDA product code for Comfort Marker 2.0 is QRN.

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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