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FDA 510(k)

RAPID-I

K-Number: K090832 · 2009-12-23

ApplicantVitrolife Sweden AB
Decision Date2009-12-23
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RAPID-I 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 2009-12-23 under 510(k) number K090832. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID-I?

RAPID-I is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K090832.

When did RAPID-I receive FDA 510(k) clearance?

RAPID-I received FDA 510(k) clearance on 2009-12-23, under 510(k) number K090832.

Who is the listed applicant for RAPID-I?

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 RAPID-I?

The FDA product code for RAPID-I is MQK.

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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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