FDA 510(k)

I81 CITE

K-Number: K862624 · 1986-08-01

Decision Date1986-08-01

Product CodeERA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

I81 CITE is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Corp.. It received FDA 510(k) clearance on 1986-08-01 under 510(k) number K862624. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I81 CITE?

I81 CITE is a medical device that received FDA 510(k) clearance on 1986-08-01. The listed applicant is Oticon Corp.. The 510(k) number is K862624.

When did I81 CITE receive FDA 510(k) clearance?

I81 CITE received FDA 510(k) clearance on 1986-08-01, under 510(k) number K862624.

Who is the listed applicant for I81 CITE?

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

What is the FDA product code for I81 CITE?

The FDA product code for I81 CITE is ERA.

Other records listing Oticon Corp. 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.

K963788PRIMOFOCUS COMPACT K932670OTICON MF K923491BTE HEARING AID PERSONIC 425 K923388BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER K923490BTE HEARING AID PERSONIC 410 K905555A-ZILICONE

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Related Devices (Code: ERA)

K123821AIO HD OTOSCOPEBlue Focus K121326LANTOS 3D EAR SCANNERLantos Technologies K110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, Inc.

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.