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Vital Signs Monitor 3

FDA 510(k)

Class II (US FDA 510(k))

510(k) K833584

by Physio-Control Corp.

Identifiers

510(k) Number
K833584 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vital Signs Monitor 3 is a medical device classified as a Patient Monitor (FDA Product Code: DPS), designed to continuously measure and display vital signs such as heart rate, blood pressure, and respiratory rate. It provides real-time monitoring of physiological parameters to support clinical assessment and patient care in acute and critical care settings.

This device is intended for use in hospital environments, including emergency rooms, intensive care units, and operating rooms. Supplied as a reusable medical instrument, it requires proper sterilization and maintenance per manufacturer guidelines. The Vital Signs Monitor 3 holds an FDA 510(k) clearance (K833584) under the Cardiovascular (CV) Advisory Committee, with a decision date of January 30, 1984. No specific MRI safety or single-use designation is noted in the available data.

Frequently asked questions

Is the Vital Signs Monitor 3 designed for single-use or can it be reused in a clinical setting?

The Vital Signs Monitor 3 is supplied as a reusable medical device. Since it is classified as a reusable instrument, it requires proper sterilization and maintenance following the manufacturer’s guidelines to ensure safe and effective use across multiple patients in acute care environments like emergency rooms or intensive care units.

What types of vital signs does the Vital Signs Monitor 3 measure, and where is it typically used?

The device continuously monitors heart rate, blood pressure, and respiratory rate in real-time. It is specifically intended for use in hospital settings, including emergency rooms, intensive care units, and operating rooms, to support clinical assessment and patient care in critical care scenarios.

How is the regulatory clearance for the Vital Signs Monitor 3 structured, and which committee was involved?

The device holds an FDA 510(k) clearance (K833584) under the Cardiovascular (CV) Advisory Committee, with a decision date of January 30, 1984. The clearance was granted as *substantially equivalent* to a predicate device, following a traditional review process. This classification reflects its role as a Patient Monitor (FDA Product Code: DPS).

Does the Vital Signs Monitor 3 have any special considerations for storage or handling beyond standard medical device protocols?

While the provided data does not specify unique storage requirements beyond typical medical device protocols, as a reusable device, it must be stored in a clean, dry environment to prevent contamination. Proper maintenance and sterilization procedures—per the manufacturer’s instructions—are critical to ensure functionality and safety before reuse in clinical settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VITAL SIGNS MONITOR 3 (K833584) — FDA 510 (k) | Innolitics, Physio-Control Vital Signs Monitor 3 | allmed.wiki, Physio Control manuals, Supported and Discontinued Items 3206600-001 | PDF | Cardiac ... - Scribd, Physio-Control Corp. — 80 FDA 510 (k)s · DeviceClearance

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Physio-Control Corp.

Sources (1)

  • FDA 510(k) K833584 24 fields · synced Oct 6, 2026