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FDA 510(k)

Ultra RapidWarm™ Blast

K-Number: K240605 · 2024-08-07

Decision Date2024-08-07
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Ultra RapidWarm™ Blast is a medical device manufactured by Vitrolife Sweden AB. It received FDA 510(k) clearance on 2024-08-07 under approval number K240605. 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 Ultra RapidWarm™ Blast?

Ultra RapidWarm™ Blast is a medical device that received FDA 510(k) clearance on 2024-08-07. It is manufactured by Vitrolife Sweden AB. The 510(k) number is K240605.

When was Ultra RapidWarm™ Blast approved by the FDA?

Ultra RapidWarm™ Blast received FDA 510(k) clearance on 2024-08-07, under approval number K240605.

What company makes Ultra RapidWarm™ Blast?

Ultra RapidWarm™ Blast is manufactured by Vitrolife Sweden AB.

What is the FDA product code for Ultra RapidWarm™ Blast?

The FDA product code for Ultra RapidWarm™ Blast is MQL.

Other Devices by Vitrolife Sweden AB

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Related Devices (Code: MQL)

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.