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FDA 510(k)

ULTRACOMPACT

K-Number: K894968 · 1989-11-08

ApplicantEutectic Electronics, Inc.
Decision Date1989-11-08
Product CodeEXY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULTRACOMPACT is the device name listed in this FDA 510(k) record. The listed applicant is Eutectic Electronics, Inc.. It received FDA 510(k) clearance on 1989-11-08 under 510(k) number K894968. The device is classified under product code EXY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACOMPACT?

ULTRACOMPACT is a medical device that received FDA 510(k) clearance on 1989-11-08. The listed applicant is Eutectic Electronics, Inc.. The 510(k) number is K894968.

When did ULTRACOMPACT receive FDA 510(k) clearance?

ULTRACOMPACT received FDA 510(k) clearance on 1989-11-08, under 510(k) number K894968.

Who is the listed applicant for ULTRACOMPACT?

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

What is the FDA product code for ULTRACOMPACT?

The FDA product code for ULTRACOMPACT is EXY.

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Other records listing Eutectic Electronics, Inc. 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.

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Related Devices (Code: EXY)

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.

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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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