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FDA 510(k)

MIS Solution

K-Number: K203835 · 2021-04-23

ApplicantNext Science, LLC
Decision Date2021-04-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MIS Solution is the device name listed in this FDA 510(k) record. The listed applicant is Next Science, LLC. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K203835. 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 MIS Solution?

MIS Solution is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Next Science, LLC. The 510(k) number is K203835.

When did MIS Solution receive FDA 510(k) clearance?

MIS Solution received FDA 510(k) clearance on 2021-04-23, under 510(k) number K203835.

Who is the listed applicant for MIS Solution?

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

What is the FDA product code for MIS Solution?

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

Other records listing Next Science, LLC 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.

K203446TorrentX Wound WashK192349Bactisure Wound LavageK163188Next Science Wound Gel (Rx)K161165Next Science Irrigation Solution

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

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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