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FDA 510(k)

ARGLAES FILM DRESSING

K-Number: K970566 · 1997-07-29

ApplicantMaersk Medical, Ltd.
Decision Date1997-07-29
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

ARGLAES FILM DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Maersk Medical, Ltd.. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K970566. 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 for Some Indications.

Frequently Asked Questions

What is the ARGLAES FILM DRESSING?

ARGLAES FILM DRESSING is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Maersk Medical, Ltd.. The 510(k) number is K970566.

When did ARGLAES FILM DRESSING receive FDA 510(k) clearance?

ARGLAES FILM DRESSING received FDA 510(k) clearance on 1997-07-29, under 510(k) number K970566.

Who is the listed applicant for ARGLAES FILM DRESSING?

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

What is the FDA product code for ARGLAES FILM DRESSING?

The FDA product code for ARGLAES FILM DRESSING is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing Maersk Medical, Ltd. 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.

K004028ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSINGK990810ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSINGK973657ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING

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.

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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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