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FDA 510(k)

BX-1000 ISOMATIC

K-Number: K820080 · 1982-07-01

ApplicantBloomex International, Inc.
Decision Date1982-07-01
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BX-1000 ISOMATIC 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 1982-07-01 under 510(k) number K820080. 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-1000 ISOMATIC?

BX-1000 ISOMATIC is a medical device that received FDA 510(k) clearance on 1982-07-01. The listed applicant is Bloomex International, Inc.. The 510(k) number is K820080.

When did BX-1000 ISOMATIC receive FDA 510(k) clearance?

BX-1000 ISOMATIC received FDA 510(k) clearance on 1982-07-01, under 510(k) number K820080.

Who is the listed applicant for BX-1000 ISOMATIC?

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-1000 ISOMATIC?

The FDA product code for BX-1000 ISOMATIC 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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