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FDA 510(k)

SLENDAIR 4000 COMPRESSION SYSTEM

K-Number: K994057 · 2000-03-03

Decision Date2000-03-03
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SLENDAIR 4000 COMPRESSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Compression Systems (Dbn) , Ltd.. It received FDA 510(k) clearance on 2000-03-03 under 510(k) number K994057. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLENDAIR 4000 COMPRESSION SYSTEM?

SLENDAIR 4000 COMPRESSION SYSTEM is a medical device that received FDA 510(k) clearance on 2000-03-03. The listed applicant is Medical Compression Systems (Dbn) , Ltd.. The 510(k) number is K994057.

When did SLENDAIR 4000 COMPRESSION SYSTEM receive FDA 510(k) clearance?

SLENDAIR 4000 COMPRESSION SYSTEM received FDA 510(k) clearance on 2000-03-03, under 510(k) number K994057.

Who is the listed applicant for SLENDAIR 4000 COMPRESSION SYSTEM?

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

What is the FDA product code for SLENDAIR 4000 COMPRESSION SYSTEM?

The FDA product code for SLENDAIR 4000 COMPRESSION SYSTEM is IRP.

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.

Other records listing Medical Compression Systems (Dbn) , 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.

View all 9 devices →

Related Devices (Code: IRP)

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

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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