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FDA 510(k)

FMS SOLO

K-Number: K002040 · 2000-09-11

ApplicantFuture Medical Systems, Inc.
Decision Date2000-09-11
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FMS SOLO 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 2000-09-11 under 510(k) number K002040. 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 SOLO?

FMS SOLO is a medical device that received FDA 510(k) clearance on 2000-09-11. The listed applicant is Future Medical Systems, Inc.. The 510(k) number is K002040.

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

FMS SOLO received FDA 510(k) clearance on 2000-09-11, under 510(k) number K002040.

Who is the listed applicant for FMS SOLO?

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 SOLO?

The FDA product code for FMS SOLO is HRX.

Other records listing Future Medical Systems, Inc. as applicant

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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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