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FDA 510(k)

DRS SYSTEM

K-Number: K981822 · 1998-06-24

Decision Date1998-06-24
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DRS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Professional Distribution Systems, Inc.. It received FDA 510(k) clearance on 1998-06-24 under 510(k) number K981822. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRS SYSTEM?

DRS SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-24. The listed applicant is Professional Distribution Systems, Inc.. The 510(k) number is K981822.

When did DRS SYSTEM receive FDA 510(k) clearance?

DRS SYSTEM received FDA 510(k) clearance on 1998-06-24, under 510(k) number K981822.

Who is the listed applicant for DRS SYSTEM?

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

What is the FDA product code for DRS SYSTEM?

The FDA product code for DRS SYSTEM is ITH.

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: ITH)

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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