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FDA 510(k)

SUN-ONE

K-Number: K842048 · 1984-11-01

ApplicantEnsun Medical Products, Inc.
Decision Date1984-11-01
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SUN-ONE is the device name listed in this FDA 510(k) record. The listed applicant is Ensun Medical Products, Inc.. It received FDA 510(k) clearance on 1984-11-01 under 510(k) number K842048. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUN-ONE?

SUN-ONE is a medical device that received FDA 510(k) clearance on 1984-11-01. The listed applicant is Ensun Medical Products, Inc.. The 510(k) number is K842048.

When did SUN-ONE receive FDA 510(k) clearance?

SUN-ONE received FDA 510(k) clearance on 1984-11-01, under 510(k) number K842048.

Who is the listed applicant for SUN-ONE?

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

What is the FDA product code for SUN-ONE?

The FDA product code for SUN-ONE is BZQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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