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FDA 510(k)

FIRST AID BAGS #1,2,3

K-Number: K830375 · 1983-05-25

ApplicantAkla, Inc.
Decision Date1983-05-25
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

FIRST AID BAGS #1,2,3 is the device name listed in this FDA 510(k) record. The listed applicant is Akla, Inc.. It received FDA 510(k) clearance on 1983-05-25 under 510(k) number K830375. 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 FIRST AID BAGS #1,2,3?

FIRST AID BAGS #1,2,3 is a medical device that received FDA 510(k) clearance on 1983-05-25. The listed applicant is Akla, Inc.. The 510(k) number is K830375.

When did FIRST AID BAGS #1,2,3 receive FDA 510(k) clearance?

FIRST AID BAGS #1,2,3 received FDA 510(k) clearance on 1983-05-25, under 510(k) number K830375.

Who is the listed applicant for FIRST AID BAGS #1,2,3?

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

What is the FDA product code for FIRST AID BAGS #1,2,3?

The FDA product code for FIRST AID BAGS #1,2,3 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 Akla, 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.

K830374RESCUE PACKK830373FIRST AID KIT

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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