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FDA 510(k)

Apis

K-Number: K182725 · 2019-05-31

ApplicantSweetbio, Inc.
Decision Date2019-05-31
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Apis is the device name listed in this FDA 510(k) record. The listed applicant is Sweetbio, Inc.. It received FDA 510(k) clearance on 2019-05-31 under 510(k) 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. The listed applicant is Sweetbio, Inc.. The 510(k) number is K182725.

When did Apis receive FDA 510(k) clearance?

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

Who is the listed applicant for Apis?

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

What is the FDA product code for Apis?

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

Other records listing Sweetbio, Inc. as applicant

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.

K222143APIS (R), VERIS (TM)

Related Devices (Code: FRO)

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.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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.

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