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FDA 510(k)

RADIO BIOAQUACARE

K-Number: K080471 · 2008-03-05

ApplicantBioartificial Gel Technologies (Bagtech), Inc.
Decision Date2008-03-05
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

RADIO BIOAQUACARE is the device name listed in this FDA 510(k) record. The listed applicant is Bioartificial Gel Technologies (Bagtech), Inc.. It received FDA 510(k) clearance on 2008-03-05 under 510(k) number K080471. 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 RADIO BIOAQUACARE?

RADIO BIOAQUACARE is a medical device that received FDA 510(k) clearance on 2008-03-05. The listed applicant is Bioartificial Gel Technologies (Bagtech), Inc.. The 510(k) number is K080471.

When did RADIO BIOAQUACARE receive FDA 510(k) clearance?

RADIO BIOAQUACARE received FDA 510(k) clearance on 2008-03-05, under 510(k) number K080471.

Who is the listed applicant for RADIO BIOAQUACARE?

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

What is the FDA product code for RADIO BIOAQUACARE?

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

Related Clinical Trials

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.

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Other records listing Bioartificial Gel Technologies (Bagtech), 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.

K072068BIOAQUACARE, MODEL C-10( VARIOUS SIZES) WITH AND WITHOUT GAUZE, BLISTER PACKAGED OR IN PLASTIC BAG CONTAINERS

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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