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 a medical device manufactured by Classys, Inc.. It received FDA 510(k) clearance on 2023-11-03 under approval 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. It is manufactured by Classys, Inc.. The 510(k) number is K230100.
When was SCIZER (SC1-M410) approved by the FDA?
SCIZER (SC1-M410) received FDA 510(k) clearance on 2023-11-03, under approval number K230100.
What company makes SCIZER (SC1-M410)?
SCIZER (SC1-M410) is manufactured by Classys, Inc..
What is the FDA product code for SCIZER (SC1-M410)?
The FDA product code for SCIZER (SC1-M410) is OHV.
Other Devices by Classys, Inc.
Related Devices (Code: OHV)
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.