Skip to content

506 Patient Monitor

by Ciriticare Systems, Inc.

510(k) K051038

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051038 Date12 Aug 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 25 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 506 Patient Monitor is a device used to monitor patient vital signs, including cardiac parameters. It is classified as a Monitor, Cardiac, which includes cardiotachometer and rate alarm. The device is designed to record basic to advanced patient data, such as pulse oximetry and invasive blood pressure.

The 506 Patient Monitor is supplied with various accessories, including thermal printer paper, blood pressure cuffs, and SaO2 probes. It is a single device, and its storage and use are subject to the manufacturer's instructions. The device has been cleared by the FDA, with a regulation number of 870.2300 and a product code of DRT.

Other devices from Criticare Systems, Inc.

See all devices from Criticare Systems, Inc. →

Questions

AI-generated answers, 25 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 506 Patient Monitor used for?

    The 506 Patient Monitor is used to monitor patient vital signs, including cardiac parameters, such as pulse oximetry and invasive blood pressure.

  • Is the 506 Patient Monitor a single-use device?

    The 506 Patient Monitor is a single device, not a single-use device, and its storage and use are subject to the manufacturer's instructions.

  • What accessories are supplied with the 506 Patient Monitor?

    The 506 Patient Monitor is supplied with various accessories, including thermal printer paper, blood pressure cuffs, and SaO2 probes.

  • What is the regulatory status of the 506 Patient Monitor?

    The 506 Patient Monitor has been cleared by the FDA, with a regulation number of 870.2300 and a product code of DRT.