FDA 510(k)

OxiplexTS200

K-Number: K232385 · 2024-03-01

Decision Date2024-03-01

Product CodeMUD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OxiplexTS200 is the device name listed in this FDA 510(k) record. The listed applicant is Iss Medical, Inc.. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K232385. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OxiplexTS200?

OxiplexTS200 is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Iss Medical, Inc.. The 510(k) number is K232385.

When did OxiplexTS200 receive FDA 510(k) clearance?

OxiplexTS200 received FDA 510(k) clearance on 2024-03-01, under 510(k) number K232385.

Who is the listed applicant for OxiplexTS200?

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

What is the FDA product code for OxiplexTS200?

The FDA product code for OxiplexTS200 is MUD.

Related Devices (Code: MUD)

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.