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FDA 510(k)

OxiplexTS200

K-Number: K232385 · 2024-03-01

ApplicantIss Medical, Inc.
Decision Date2024-03-01
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OxiplexTS200 is a medical device manufactured by Iss Medical, Inc.. It received FDA 510(k) clearance on 2024-03-01 under approval 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. It is manufactured by Iss Medical, Inc.. The 510(k) number is K232385.

When was OxiplexTS200 approved by the FDA?

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

What company makes OxiplexTS200?

OxiplexTS200 is manufactured by Iss Medical, Inc..

What is the FDA product code for OxiplexTS200?

The FDA product code for OxiplexTS200 is MUD.

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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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