FDA 510(k)

MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)

K-Number: K913533 · 1991-11-07

Decision Date1991-11-07

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard Co.. It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K913533. 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 MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)?

MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K913533.

When did MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) receive FDA 510(k) clearance?

MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) received FDA 510(k) clearance on 1991-11-07, under 510(k) number K913533.

Who is the listed applicant for MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)?

The FDA 510(k) record lists Hewlett-Packard Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)?

The FDA product code for MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) 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.