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FDA 510(k)

BX-200 SC

K-Number: K943185 · 1995-08-14

ApplicantBloomex International, Inc.
Decision Date1995-08-14
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

BX-200 SC 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 1995-08-14 under 510(k) number K943185. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BX-200 SC?

BX-200 SC is a medical device that received FDA 510(k) clearance on 1995-08-14. The listed applicant is Bloomex International, Inc.. The 510(k) number is K943185.

When did BX-200 SC receive FDA 510(k) clearance?

BX-200 SC received FDA 510(k) clearance on 1995-08-14, under 510(k) number K943185.

Who is the listed applicant for BX-200 SC?

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-200 SC?

The FDA product code for BX-200 SC is IPF.

Other records listing Bloomex International, Inc. as applicant

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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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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