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FDA 510(k)

TTM5000 TELEPHONIC EKG MONITOR

K-Number: K973267 · 1998-01-29

ApplicantHds Medical, Inc.
Decision Date1998-01-29
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TTM5000 TELEPHONIC EKG MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Hds Medical, Inc.. It received FDA 510(k) clearance on 1998-01-29 under 510(k) number K973267. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TTM5000 TELEPHONIC EKG MONITOR?

TTM5000 TELEPHONIC EKG MONITOR is a medical device that received FDA 510(k) clearance on 1998-01-29. The listed applicant is Hds Medical, Inc.. The 510(k) number is K973267.

When did TTM5000 TELEPHONIC EKG MONITOR receive FDA 510(k) clearance?

TTM5000 TELEPHONIC EKG MONITOR received FDA 510(k) clearance on 1998-01-29, under 510(k) number K973267.

Who is the listed applicant for TTM5000 TELEPHONIC EKG MONITOR?

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

What is the FDA product code for TTM5000 TELEPHONIC EKG MONITOR?

The FDA product code for TTM5000 TELEPHONIC EKG MONITOR is DXH. This falls under the Hematology category.

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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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