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FDA 510(k)

EGNELL COMPACT, TYPE EHV

K-Number: K812020 · 1981-10-20

ApplicantEgnell, Inc.
Decision Date1981-10-20
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EGNELL COMPACT, TYPE EHV is the device name listed in this FDA 510(k) record. The listed applicant is Egnell, Inc.. It received FDA 510(k) clearance on 1981-10-20 under 510(k) number K812020. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EGNELL COMPACT, TYPE EHV?

EGNELL COMPACT, TYPE EHV is a medical device that received FDA 510(k) clearance on 1981-10-20. The listed applicant is Egnell, Inc.. The 510(k) number is K812020.

When did EGNELL COMPACT, TYPE EHV receive FDA 510(k) clearance?

EGNELL COMPACT, TYPE EHV received FDA 510(k) clearance on 1981-10-20, under 510(k) number K812020.

Who is the listed applicant for EGNELL COMPACT, TYPE EHV?

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

What is the FDA product code for EGNELL COMPACT, TYPE EHV?

The FDA product code for EGNELL COMPACT, TYPE EHV is BTA.

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Other records listing Egnell, 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: BTA)

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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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