FDA 510(k)

PHONIC EAR, MODEL PE 1800

K-Number: K862162 · 1986-07-18

Decision Date1986-07-18

Product CodeETW

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

PHONIC EAR, MODEL PE 1800 is the device name listed in this FDA 510(k) record. The listed applicant is Phonic Ear, Inc.. It received FDA 510(k) clearance on 1986-07-18 under 510(k) number K862162. The device is classified under product code ETW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHONIC EAR, MODEL PE 1800?

PHONIC EAR, MODEL PE 1800 is a medical device that received FDA 510(k) clearance on 1986-07-18. The listed applicant is Phonic Ear, Inc.. The 510(k) number is K862162.

When did PHONIC EAR, MODEL PE 1800 receive FDA 510(k) clearance?

PHONIC EAR, MODEL PE 1800 received FDA 510(k) clearance on 1986-07-18, under 510(k) number K862162.

Who is the listed applicant for PHONIC EAR, MODEL PE 1800?

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

What is the FDA product code for PHONIC EAR, MODEL PE 1800?

The FDA product code for PHONIC EAR, MODEL PE 1800 is ETW.

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Other records listing Phonic Ear, 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.