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FDA 510(k)

MIRACLE 98

K-Number: K031010 · 2003-06-25

ApplicantSb Lucius, Inc.
Decision Date2003-06-25
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIRACLE 98 is the device name listed in this FDA 510(k) record. The listed applicant is Sb Lucius, Inc.. It received FDA 510(k) clearance on 2003-06-25 under 510(k) number K031010. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIRACLE 98?

MIRACLE 98 is a medical device that received FDA 510(k) clearance on 2003-06-25. The listed applicant is Sb Lucius, Inc.. The 510(k) number is K031010.

When did MIRACLE 98 receive FDA 510(k) clearance?

MIRACLE 98 received FDA 510(k) clearance on 2003-06-25, under 510(k) number K031010.

Who is the listed applicant for MIRACLE 98?

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

What is the FDA product code for MIRACLE 98?

The FDA product code for MIRACLE 98 is EJT.

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Other records listing Sb Lucius, Inc. as applicant

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Related Devices (Code: EJT)

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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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