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FDA 510(k)

BMR 1900 PHISIO

K-Number: K223361 · 2023-06-10

ApplicantSorin Group Italia S.R.L.
Decision Date2023-06-10
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BMR 1900 PHISIO is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2023-06-10 under approval number K223361. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BMR 1900 PHISIO?

BMR 1900 PHISIO is a medical device that received FDA 510(k) clearance on 2023-06-10. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K223361.

When was BMR 1900 PHISIO approved by the FDA?

BMR 1900 PHISIO received FDA 510(k) clearance on 2023-06-10, under approval number K223361.

What company makes BMR 1900 PHISIO?

BMR 1900 PHISIO is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for BMR 1900 PHISIO?

The FDA product code for BMR 1900 PHISIO is DTN.

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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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