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FDA 510(k)

EM Provisional

K-Number: K191751 · 2019-12-16

ApplicantHiossen, Inc.
Decision Date2019-12-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EM Provisional is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2019-12-16 under 510(k) number K191751. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EM Provisional?

EM Provisional is a medical device that received FDA 510(k) clearance on 2019-12-16. The listed applicant is Hiossen, Inc.. The 510(k) number is K191751.

When did EM Provisional receive FDA 510(k) clearance?

EM Provisional received FDA 510(k) clearance on 2019-12-16, under 510(k) number K191751.

Who is the listed applicant for EM Provisional?

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

What is the FDA product code for EM Provisional?

The FDA product code for EM Provisional is DZE.

Other records listing Hiossen, Inc. as applicant

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Related Devices (Code: DZE)

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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