FDA 510(k)

MBI-4

K-Number: K810247 · 1981-03-10

Decision Date1981-03-10

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

MBI-4 is the device name listed in this FDA 510(k) record. The listed applicant is Bloomex International, Inc.. It received FDA 510(k) clearance on 1981-03-10 under 510(k) number K810247. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MBI-4?

MBI-4 is a medical device that received FDA 510(k) clearance on 1981-03-10. The listed applicant is Bloomex International, Inc.. The 510(k) number is K810247.

When did MBI-4 receive FDA 510(k) clearance?

MBI-4 received FDA 510(k) clearance on 1981-03-10, under 510(k) number K810247.

Who is the listed applicant for MBI-4?

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

What is the FDA product code for MBI-4?

The FDA product code for MBI-4 is IPF.

Other records listing Bloomex International, Inc. as applicant

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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.