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FDA 510(k)

HI-TECH LAB MODEL CONCHA ALL IN EAR

K-Number: K853967 · 1985-12-27

ApplicantHi-Tech Laboratories, Inc.
Decision Date1985-12-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HI-TECH LAB MODEL CONCHA ALL IN EAR is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Tech Laboratories, Inc.. It received FDA 510(k) clearance on 1985-12-27 under 510(k) number K853967. 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 HI-TECH LAB MODEL CONCHA ALL IN EAR?

HI-TECH LAB MODEL CONCHA ALL IN EAR is a medical device that received FDA 510(k) clearance on 1985-12-27. The listed applicant is Hi-Tech Laboratories, Inc.. The 510(k) number is K853967.

When did HI-TECH LAB MODEL CONCHA ALL IN EAR receive FDA 510(k) clearance?

HI-TECH LAB MODEL CONCHA ALL IN EAR received FDA 510(k) clearance on 1985-12-27, under 510(k) number K853967.

Who is the listed applicant for HI-TECH LAB MODEL CONCHA ALL IN EAR?

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

What is the FDA product code for HI-TECH LAB MODEL CONCHA ALL IN EAR?

The FDA product code for HI-TECH LAB MODEL CONCHA ALL IN EAR is ESD.

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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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