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FDA 510(k)

OMNI Skirted Heads

K-Number: K152919 · 2016-03-10

ApplicantOmni Life Science, Inc.
Decision Date2016-03-10
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNI Skirted Heads is the device name listed in this FDA 510(k) record. The listed applicant is Omni Life Science, Inc.. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K152919. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI Skirted Heads?

OMNI Skirted Heads is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Omni Life Science, Inc.. The 510(k) number is K152919.

When did OMNI Skirted Heads receive FDA 510(k) clearance?

OMNI Skirted Heads received FDA 510(k) clearance on 2016-03-10, under 510(k) number K152919.

Who is the listed applicant for OMNI Skirted Heads?

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

What is the FDA product code for OMNI Skirted Heads?

The FDA product code for OMNI Skirted Heads is LZO.

Other records listing Omni Life Science, 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: LZO)

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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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