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FDA 510(k)

TS2000 MEDICAL DEVICE MONITOR

K-Number: K973640 · 1998-03-12

ApplicantTrincore Systems, Inc.
Decision Date1998-03-12
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TS2000 MEDICAL DEVICE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Trincore Systems, Inc.. It received FDA 510(k) clearance on 1998-03-12 under 510(k) number K973640. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TS2000 MEDICAL DEVICE MONITOR?

TS2000 MEDICAL DEVICE MONITOR is a medical device that received FDA 510(k) clearance on 1998-03-12. The listed applicant is Trincore Systems, Inc.. The 510(k) number is K973640.

When did TS2000 MEDICAL DEVICE MONITOR receive FDA 510(k) clearance?

TS2000 MEDICAL DEVICE MONITOR received FDA 510(k) clearance on 1998-03-12, under 510(k) number K973640.

Who is the listed applicant for TS2000 MEDICAL DEVICE MONITOR?

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

What is the FDA product code for TS2000 MEDICAL DEVICE MONITOR?

The FDA product code for TS2000 MEDICAL DEVICE MONITOR is MSX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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