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FDA 510(k)

ELECTRO-PALATE

K-Number: K840892 · 1984-05-22

ApplicantCisko Systems
Decision Date1984-05-22
Product CodeESE
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ELECTRO-PALATE is the device name listed in this FDA 510(k) record. The listed applicant is Cisko Systems. It received FDA 510(k) clearance on 1984-05-22 under 510(k) number K840892. The device is classified under product code ESE. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRO-PALATE?

ELECTRO-PALATE is a medical device that received FDA 510(k) clearance on 1984-05-22. The listed applicant is Cisko Systems. The 510(k) number is K840892.

When did ELECTRO-PALATE receive FDA 510(k) clearance?

ELECTRO-PALATE received FDA 510(k) clearance on 1984-05-22, under 510(k) number K840892.

Who is the listed applicant for ELECTRO-PALATE?

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

What is the FDA product code for ELECTRO-PALATE?

The FDA product code for ELECTRO-PALATE is ESE.

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Related Devices (Code: ESE)

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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