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FDA 510(k)

SCIZER (SC1-M410)

K-Number: K230100 · 2023-11-03

ApplicantClassys, Inc.
Decision Date2023-11-03
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCIZER (SC1-M410) is the device name listed in this FDA 510(k) record. The listed applicant is Classys, Inc.. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K230100. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCIZER (SC1-M410)?

SCIZER (SC1-M410) is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Classys, Inc.. The 510(k) number is K230100.

When did SCIZER (SC1-M410) receive FDA 510(k) clearance?

SCIZER (SC1-M410) received FDA 510(k) clearance on 2023-11-03, under 510(k) number K230100.

Who is the listed applicant for SCIZER (SC1-M410)?

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

What is the FDA product code for SCIZER (SC1-M410)?

The FDA product code for SCIZER (SC1-M410) is OHV.

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Other records listing Classys, Inc. as applicant

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Related Devices (Code: OHV)

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

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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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