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FDA 510(k)

SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS

K-Number: K802687 · 1981-02-04

ApplicantIntelligent Software Systems, Inc.
Decision Date1981-02-04
Product CodeILQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Software Systems, Inc.. It received FDA 510(k) clearance on 1981-02-04 under 510(k) number K802687. The device is classified under product code ILQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS?

SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS is a medical device that received FDA 510(k) clearance on 1981-02-04. The listed applicant is Intelligent Software Systems, Inc.. The 510(k) number is K802687.

When did SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS receive FDA 510(k) clearance?

SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS received FDA 510(k) clearance on 1981-02-04, under 510(k) number K802687.

Who is the listed applicant for SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS?

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

What is the FDA product code for SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS?

The FDA product code for SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS is ILQ.

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Related Devices (Code: ILQ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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