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 a medical device manufactured by Medical Precision BV. It received FDA 510(k) clearance on 2023-03-30 under approval 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. It is manufactured by Medical Precision BV. The 510(k) number is K222112.
When was Comfort Marker 2.0 approved by the FDA?
Comfort Marker 2.0 received FDA 510(k) clearance on 2023-03-30, under approval number K222112.
What company makes Comfort Marker 2.0?
Comfort Marker 2.0 is manufactured by Medical Precision BV.
What is the FDA product code for Comfort Marker 2.0?
The FDA product code for Comfort Marker 2.0 is QRN.
Other Devices by Medical Precision BV
Related Devices (Code: 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.