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FDA 510(k)

STARKEY MODEL HAL-1

K-Number: K821908 · 1982-08-03

ApplicantStarkey Laboratories, Inc.
Decision Date1982-08-03
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

STARKEY MODEL HAL-1 is the device name listed in this FDA 510(k) record. The listed applicant is Starkey Laboratories, Inc.. It received FDA 510(k) clearance on 1982-08-03 under 510(k) number K821908. 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 STARKEY MODEL HAL-1?

STARKEY MODEL HAL-1 is a medical device that received FDA 510(k) clearance on 1982-08-03. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K821908.

When did STARKEY MODEL HAL-1 receive FDA 510(k) clearance?

STARKEY MODEL HAL-1 received FDA 510(k) clearance on 1982-08-03, under 510(k) number K821908.

Who is the listed applicant for STARKEY MODEL HAL-1?

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

What is the FDA product code for STARKEY MODEL HAL-1?

The FDA product code for STARKEY MODEL HAL-1 is ETW.

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Other records listing Starkey Laboratories, Inc. as applicant

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Related Devices (Code: ETW)

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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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