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FDA 510(k)

EUROSUN MODELS - ES-2400, ES-VHO AND ES-16

K-Number: K904644 · 1990-12-28

ApplicantEurosun, Inc.
Decision Date1990-12-28
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EUROSUN MODELS - ES-2400, ES-VHO AND ES-16 is the device name listed in this FDA 510(k) record. The listed applicant is Eurosun, Inc.. It received FDA 510(k) clearance on 1990-12-28 under 510(k) number K904644. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROSUN MODELS - ES-2400, ES-VHO AND ES-16?

EUROSUN MODELS - ES-2400, ES-VHO AND ES-16 is a medical device that received FDA 510(k) clearance on 1990-12-28. The listed applicant is Eurosun, Inc.. The 510(k) number is K904644.

When did EUROSUN MODELS - ES-2400, ES-VHO AND ES-16 receive FDA 510(k) clearance?

EUROSUN MODELS - ES-2400, ES-VHO AND ES-16 received FDA 510(k) clearance on 1990-12-28, under 510(k) number K904644.

Who is the listed applicant for EUROSUN MODELS - ES-2400, ES-VHO AND ES-16?

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

What is the FDA product code for EUROSUN MODELS - ES-2400, ES-VHO AND ES-16?

The FDA product code for EUROSUN MODELS - ES-2400, ES-VHO AND ES-16 is LEJ.

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Official Source

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