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FDA 510(k)

FMS DUO

K-Number: K954465 · 1995-11-09

ApplicantFuture Medical Systems, Inc.
Decision Date1995-11-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FMS DUO is the device name listed in this FDA 510(k) record. The listed applicant is Future Medical Systems, Inc.. It received FDA 510(k) clearance on 1995-11-09 under 510(k) number K954465. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FMS DUO?

FMS DUO is a medical device that received FDA 510(k) clearance on 1995-11-09. The listed applicant is Future Medical Systems, Inc.. The 510(k) number is K954465.

When did FMS DUO receive FDA 510(k) clearance?

FMS DUO received FDA 510(k) clearance on 1995-11-09, under 510(k) number K954465.

Who is the listed applicant for FMS DUO?

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

What is the FDA product code for FMS DUO?

The FDA product code for FMS DUO is HRX.

Other records listing Future Medical Systems, 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.

K023963ADHOC CLAWK021030TITANIUM CANNULATED INTERFERENCE SCREWK013685PLLA CANNULATED INTERFERENCE SCREWK002040FMS SOLOK980808ENDO FMS UROLOGYK955500FMS ARTHOPROBE

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Related Devices (Code: HRX)

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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