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FDA 510(k)

AROMAPATCH

K-Number: K984345 · 1999-03-19

ApplicantEnvis, Inc.
Decision Date1999-03-19
Product CodeLRD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AROMAPATCH is the device name listed in this FDA 510(k) record. The listed applicant is Envis, Inc.. It received FDA 510(k) clearance on 1999-03-19 under 510(k) number K984345. The device is classified under product code LRD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AROMAPATCH?

AROMAPATCH is a medical device that received FDA 510(k) clearance on 1999-03-19. The listed applicant is Envis, Inc.. The 510(k) number is K984345.

When did AROMAPATCH receive FDA 510(k) clearance?

AROMAPATCH received FDA 510(k) clearance on 1999-03-19, under 510(k) number K984345.

Who is the listed applicant for AROMAPATCH?

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

What is the FDA product code for AROMAPATCH?

The FDA product code for AROMAPATCH is LRD.

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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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