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FDA 510(k)

OVOIL-150, MODEL 5002

K-Number: K991351 · 2000-02-25

ApplicantVitrolife Sweden AB
Decision Date2000-02-25
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OVOIL-150, MODEL 5002 is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2000-02-25 under 510(k) number K991351. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVOIL-150, MODEL 5002?

OVOIL-150, MODEL 5002 is a medical device that received FDA 510(k) clearance on 2000-02-25. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K991351.

When did OVOIL-150, MODEL 5002 receive FDA 510(k) clearance?

OVOIL-150, MODEL 5002 received FDA 510(k) clearance on 2000-02-25, under 510(k) number K991351.

Who is the listed applicant for OVOIL-150, MODEL 5002?

The FDA 510(k) record lists Vitrolife Sweden AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OVOIL-150, MODEL 5002?

The FDA product code for OVOIL-150, MODEL 5002 is MQL.

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Related Devices (Code: MQL)

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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