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FDA 510(k)

Apis

K-Number: K182725 · 2019-05-31

Decision Date2019-05-31
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Apis is a medical device manufactured by Sweetbio, Inc.. It received FDA 510(k) clearance on 2019-05-31 under approval number K182725. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Apis?

Apis is a medical device that received FDA 510(k) clearance on 2019-05-31. It is manufactured by Sweetbio, Inc.. The 510(k) number is K182725.

When was Apis approved by the FDA?

Apis received FDA 510(k) clearance on 2019-05-31, under approval number K182725.

What company makes Apis?

Apis is manufactured by Sweetbio, Inc..

What is the FDA product code for Apis?

The FDA product code for Apis is FRO. This falls under the Anesthesiology category.

Other Devices by Sweetbio, Inc.

Related Devices (Code: FRO)

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.