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FDA 510(k)

ALKA FIRST AID KIT

K-Number: K831657 · 1983-08-24

ApplicantAlka, Inc.
Decision Date1983-08-24
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ALKA FIRST AID KIT is the device name listed in this FDA 510(k) record. The listed applicant is Alka, Inc.. It received FDA 510(k) clearance on 1983-08-24 under 510(k) number K831657. 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 ALKA FIRST AID KIT?

ALKA FIRST AID KIT is a medical device that received FDA 510(k) clearance on 1983-08-24. The listed applicant is Alka, Inc.. The 510(k) number is K831657.

When did ALKA FIRST AID KIT receive FDA 510(k) clearance?

ALKA FIRST AID KIT received FDA 510(k) clearance on 1983-08-24, under 510(k) number K831657.

Who is the listed applicant for ALKA FIRST AID KIT?

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

What is the FDA product code for ALKA FIRST AID KIT?

The FDA product code for ALKA FIRST AID KIT 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.

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.

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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