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FDA 510(k)

EUROLINE A-675 SERIS

K-Number: K963519 · 1996-09-27

ApplicantStarkey Laboratories, Inc.
Decision Date1996-09-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EUROLINE A-675 SERIS 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 1996-09-27 under 510(k) number K963519. 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 EUROLINE A-675 SERIS?

EUROLINE A-675 SERIS is a medical device that received FDA 510(k) clearance on 1996-09-27. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K963519.

When did EUROLINE A-675 SERIS receive FDA 510(k) clearance?

EUROLINE A-675 SERIS received FDA 510(k) clearance on 1996-09-27, under 510(k) number K963519.

Who is the listed applicant for EUROLINE A-675 SERIS?

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 EUROLINE A-675 SERIS?

The FDA product code for EUROLINE A-675 SERIS is ESD.

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Other records listing Starkey Laboratories, 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.

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