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FDA 510(k)

BX-400 JESSE JIMBODY

K-Number: K813410 · 1982-03-08

ApplicantBloomex International, Inc.
Decision Date1982-03-08
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BX-400 JESSE JIMBODY 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 1982-03-08 under 510(k) number K813410. 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 BX-400 JESSE JIMBODY?

BX-400 JESSE JIMBODY is a medical device that received FDA 510(k) clearance on 1982-03-08. The listed applicant is Bloomex International, Inc.. The 510(k) number is K813410.

When did BX-400 JESSE JIMBODY receive FDA 510(k) clearance?

BX-400 JESSE JIMBODY received FDA 510(k) clearance on 1982-03-08, under 510(k) number K813410.

Who is the listed applicant for BX-400 JESSE JIMBODY?

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 BX-400 JESSE JIMBODY?

The FDA product code for BX-400 JESSE JIMBODY is IPF.

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Other records listing Bloomex International, Inc. as applicant

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Related Devices (Code: IPF)

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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