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FDA 510(k)

ELITE

K-Number: K810246 · 1981-03-16

ApplicantBloomex International, Inc.
Decision Date1981-03-16
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELITE 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 1981-03-16 under 510(k) number K810246. 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 ELITE?

ELITE is a medical device that received FDA 510(k) clearance on 1981-03-16. The listed applicant is Bloomex International, Inc.. The 510(k) number is K810246.

When did ELITE receive FDA 510(k) clearance?

ELITE received FDA 510(k) clearance on 1981-03-16, under 510(k) number K810246.

Who is the listed applicant for ELITE?

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 ELITE?

The FDA product code for ELITE 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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