FDA 510(k)

800 BLUE

K-Number: K830303 · 1983-03-07

Decision Date1983-03-07

Product CodeESD

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

800 BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Electone, Inc.. It received FDA 510(k) clearance on 1983-03-07 under 510(k) number K830303. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 800 BLUE?

800 BLUE is a medical device that received FDA 510(k) clearance on 1983-03-07. The listed applicant is Electone, Inc.. The 510(k) number is K830303.

When did 800 BLUE receive FDA 510(k) clearance?

800 BLUE received FDA 510(k) clearance on 1983-03-07, under 510(k) number K830303.

Who is the listed applicant for 800 BLUE?

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

What is the FDA product code for 800 BLUE?

The FDA product code for 800 BLUE is ESD.

Other records listing Electone, Inc. as applicant

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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.