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Model 78801A Patient Monitors

by Hewlett-Packard Co. 510(k)

Active United States

510(k) K790454

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790454 Date3 Apr 1979ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Model 78801a Patient Monitors is a cardiac monitor, including cardiotachometer and rate alarm, classified as a device class 2. It is used in the medical specialty of cardiovascular care.

The device is supplied by Hewlett-Packard Co. and has a product code of DRT, with a regulation number of 870.2300. It has been cleared with a Traditional clearance type and is classified as substantially equivalent.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Model 78801a Patient Monitors used for?

    The Model 78801a Patient Monitors is used in the medical specialty of cardiovascular care, specifically as a cardiac monitor, including cardiotachometer and rate alarm.

  • Who supplies the Model 78801a Patient Monitors?

    The device is supplied by Hewlett-Packard Co.

  • What is the product code of the Model 78801a Patient Monitors?

    The product code of the Model 78801a Patient Monitors is DRT, with a regulation number of 870.2300.

  • Is the Model 78801a Patient Monitors a single-use or reusable device?

    The device data does not specify whether the Model 78801a Patient Monitors is single-use or reusable.

  • What is the regulatory classification of the Model 78801a Patient Monitors?

    The Model 78801a Patient Monitors is classified as a device class 2, and has been cleared with a Traditional clearance type.