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FDA 510(k)

OXY-1 System

K-Number: K223161 · 2023-02-23

ApplicantAbiomed, Inc.
Decision Date2023-02-23
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXY-1 System is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K223161. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXY-1 System?

OXY-1 System is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Abiomed, Inc.. The 510(k) number is K223161.

When did OXY-1 System receive FDA 510(k) clearance?

OXY-1 System received FDA 510(k) clearance on 2023-02-23, under 510(k) number K223161.

Who is the listed applicant for OXY-1 System?

The FDA 510(k) record lists Abiomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXY-1 System?

The FDA product code for OXY-1 System is DTZ.

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Related Devices (Code: DTZ)

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.

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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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