FDA 510(k)

ARGUS PB-3000

K-Number: K221056 · 2023-07-06

Decision Date2023-07-06

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ARGUS PB-3000 is a medical device manufactured by Schiller AG. It received FDA 510(k) clearance on 2023-07-06 under approval number K221056. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARGUS PB-3000?

ARGUS PB-3000 is a medical device that received FDA 510(k) clearance on 2023-07-06. It is manufactured by Schiller AG. The 510(k) number is K221056.

When was ARGUS PB-3000 approved by the FDA?

ARGUS PB-3000 received FDA 510(k) clearance on 2023-07-06, under approval number K221056.

What company makes ARGUS PB-3000?

ARGUS PB-3000 is manufactured by Schiller AG.

What is the FDA product code for ARGUS PB-3000?

The FDA product code for ARGUS PB-3000 is MHX.

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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.