FDA 510(k)

ZOOM

K-Number: K172768 · 2018-04-24

ApplicantZetta Medical Technologies, LLC

Decision Date2018-04-24

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ZOOM is the device name listed in this FDA 510(k) record. The listed applicant is Zetta Medical Technologies, LLC. It received FDA 510(k) clearance on 2018-04-24 under 510(k) number K172768. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOOM?

ZOOM is a medical device that received FDA 510(k) clearance on 2018-04-24. The listed applicant is Zetta Medical Technologies, LLC. The 510(k) number is K172768.

When did ZOOM receive FDA 510(k) clearance?

ZOOM received FDA 510(k) clearance on 2018-04-24, under 510(k) number K172768.

Who is the listed applicant for ZOOM?

The FDA 510(k) record lists Zetta Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZOOM?

The FDA product code for ZOOM is LLZ.

Other records listing Zetta Medical Technologies, LLC 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.

K170273Z-DOSE29 K160852Zia

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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.