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FDA 510(k)

Altaviz Needle Kit II

K-Number: K231261 · 2023-07-27

ApplicantAltaviz, LLC
Decision Date2023-07-27
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Altaviz Needle Kit II is a medical device manufactured by Altaviz, LLC. It received FDA 510(k) clearance on 2023-07-27 under approval number K231261. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altaviz Needle Kit II?

Altaviz Needle Kit II is a medical device that received FDA 510(k) clearance on 2023-07-27. It is manufactured by Altaviz, LLC. The 510(k) number is K231261.

When was Altaviz Needle Kit II approved by the FDA?

Altaviz Needle Kit II received FDA 510(k) clearance on 2023-07-27, under approval number K231261.

What company makes Altaviz Needle Kit II?

Altaviz Needle Kit II is manufactured by Altaviz, LLC.

What is the FDA product code for Altaviz Needle Kit II?

The FDA product code for Altaviz Needle Kit II is FMI.

Other Devices by Altaviz, LLC

Related Devices (Code: FMI)

Official Source

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